Implantable electroacupuncture system and method

ABSTRACT

A method comprises generating, by an implantable stimulator, stimulation sessions at a duty cycle that is less than 0.05 and applying, by the implantable stimulator in accordance with the duty cycle, the stimulation sessions to a patient. The duty cycle is a ratio of T 3  to T 4 . Each stimulation session included in the stimulation sessions has a duration of T 3  minutes and occurs at a rate of once every T 4  minutes. The implantable stimulator is powered by a primary battery located within the implantable stimulator and having an internal impedance greater than 5 ohms.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/918,781, filed Mar. 12, 2018, which application is acontinuation application of U.S. patent application Ser. No. 15/421,294,filed Jan. 31, 2017, and issued as U.S. Pat. No. 9,949,893, whichapplication is a continuation application of U.S. patent applicationSer. No. 14/859,098, filed Sep. 18, 2015 and issued as U.S. Pat. No.9,566,213, which application is a continuation application of U.S.patent application Ser. No. 13/736,033, filed Jan. 7, 2013 and issued asU.S. Pat. No. 9,314,399, which application is a continuation-in-partapplication of U.S. patent application Ser. No. 13/622,497, filed Sep.19, 2012 and issued as U.S. Pat. No. 8,938,297. U.S. patent applicationSer. No. 13/736,033 also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 61/606,995, filed Mar. 6, 2012;U.S. Provisional Patent Application No. 61/609,875, filed Mar. 12, 2012;U.S. Provisional Patent Application No. 61/672,257, filed Jul. 16, 2012;U.S. Provisional Patent Application No. 61/672,661, filed Jul. 17, 2012;U.S. Provisional Patent Application No. 61/673,254, filed Jul. 19, 2012;U.S. Provisional Patent Application No. 61/674,691, filed Jul. 23, 2012;and U.S. Provisional Patent Application No. 61/676,275, filed Jul. 26,2012. All of these applications are incorporated herein by reference intheir respective entireties.

BACKGROUND INFORMATION

An estimated 1.1 billion adults worldwide are overweight or obese, onehundred thirty million of whom are adults in the United States. See,Haslam, D., Sattar, N., & Lean, M. (2006). Obesity—time to wake up. Bmj,333(7569), 640-642; Flegal, K. M., Carroll, M. D., Ogden, C. L., &Johnson, C. L. (2002). Prevalence and trends in obesity among US adults,1999-2000. JAMA: the journal of the American Medical Association,288(14), 1723-1727. The prevalence of obesity in the United States amongadults has tripled over the last three decades. Furthermore, anoverweight or obese state increases the risk for all-cause mortality,morbidity from hypertension, dyslipidemia, type two diabetes, coronaryheart disease (CHD), stroke, gallbladder disease, osteoarthritis, sleepapnea, respiratory problems, and certain cancers.

Obesity is shown to reduce life expectancy by seven years at the age of40. Weight control, on the other hand, improves blood pressure,triglyceride levels, LDL and HDL cholesterol, blood glucose, andhemoglobin A_(1c) levels in type two diabetics.

Obesity is defined as having an excessive amount of body fat. Obesity isdiagnosed by the Body Mass Index—a calculation of one's weight inrelationship to one's height. A person with obesity has a body massindex (BMI) of 30 or higher. A person who is not considered obese butoverweight has a body mass index above 25 but below 30. Body mass indexis calculated by dividing one's weight in kilograms by one's height inmeters squared. However, muscular people and athletes may have a BMI inthe obese category even though they may not have excess body fat; aperson with great muscle mass with a BMI of 30 or higher may not beconsidered obese.

Although there are genetic and hormonal influences on body weight,obesity occurs when a person takes in more calories than he burnsthrough exercise and normal daily activities. The body stores theseexcess calories as fat. Obesity usually results from a combination ofcauses and contributing factors including:

1. Inactivity

2. Unhealthy diet and eating habits

3. Pregnancy

4. Lack of sleep

5. Certain Medications

6. Medical problems

7. Age

8. Social and economic issues

Obesity is associated with dyslipidemia, defined as an abnormal lipidstatus. Most commonly, this is manifested as high cholesterol (alsocalled “hypercholesterolemia”). Other common lipid abnormalities areelevated low-density lipoprotein (LDL) cholesterol, Lp(a), andtriglycerides; low levels of high-density lipoprotein (HDL); and manysmall dense LDL particles. These abnormalities can be found alone or incombination.

Cholesterol is a waxy substance that is found in the fats (the lipids)in the blood. While the body needs cholesterol to continue buildinghealthy cells, having high cholesterol can increase a patient's risk ofheart disease. There are three different types of cholesterol:low-density lipoprotein or “LDL,” very-low-density lipoprotein or“VLDL,” and high-density lipoprotein or “HDL.” While triglycerides andcholesterol are both types of fats that circulate in the blood,triglycerides store unused calories and provide the body with energywhile cholesterol is used to build cells and some hormones.

About thirty nine percent of global adults have high cholesterol and athird of global ischemic heart disease is attributable to highcholesterol. Raised cholesterol, in particular, is estimated to causeabout 2.6 million deaths, which is 4.5% of total deaths, and 29.7million disability adjusted life years. It is a major cause of diseaseburden in both developed and developing nations as a risk factor forischemic heart disease and stroke. In high income countries, the diseaseburden is even greater with about half of adults having raisedcholesterol.

An alternative approach for treating obesity, diabetes, high cholesteroland a host of other physiological conditions, illnesses, deficienciesand disorders is acupuncture, which includes traditional acupuncture andacupressure. Acupuncture has been practiced in Eastern civilizations(principally in China, but also in other Asian countries) for at least2500 years. It is still practiced today throughout many parts of theworld, including the United States and Europe. A good summary of thehistory of acupuncture, and its potential applications may be found inCheung, et al., “The Mechanism of Acupuncture Therapy and Clinical CaseStudies”, (Taylor & Francis, publisher) (2001) ISBN 0-415-27254-8,hereafter referred to as “Cheung, Mechanism of Acupuncture, 2001.” TheForward, as well as Chapters 1-3, 5, 7, 8, 12 and 13 of Cheung,Mechanism of Acupuncture, 2001, are incorporated herein by reference.

Despite the practice in Eastern countries for over 2500 years, it wasnot until President Richard Nixon visited China (in 1972) thatacupuncture began to be accepted in the West, such as the United Statesand Europe. One of the reporters who accompanied Nixon during his visitto China, James Reston, from the New York Times, received acupuncture inChina for post-operative pain after undergoing an emergency appendectomyunder standard anesthesia. Reston experienced pain relief from theacupuncture and wrote about it in The New York Times. In 1973 theAmerican Internal Revenue Service allowed acupuncture to be deducted asa medical expense. Following Nixon's visit to China, and as immigrantsbegan flowing from China to Western countries, the demand foracupuncture increased steadily. Today, acupuncture therapy is viewed bymany as a viable alternative form of medical treatment, alongsideWestern therapies. Moreover, acupuncture treatment is now covered, atleast in part, by most insurance carriers. Further, payment foracupuncture services consumes a not insignificant portion of healthcareexpenditures in the U.S. and Europe. See, generally, Cheung, Mechanismof Acupuncture, 2001, vii.

Acupuncture is an alternative medicine that treats patients by insertionand manipulation of needles in the body at selected points. See, Novak,Patricia D. et al (1995). Dorland's Pocket Medical Dictionary (25thed.), Philadelphia: (W.B. Saunders Publisher), ISBN 0-7216-5738-9. Thelocations where the acupuncture needles are inserted are referred toherein as “acupuncture points” or simply just “acupoints”. The locationof acupoints in the human body has been developed over thousands ofyears of acupuncture practice, and maps showing the location ofacupoints in the human body are readily available in acupuncture booksor online. For example, see, “Acupuncture Points Map,” found online at:http://www.acupuncturehealing.org/acupuncture-points-map.html. Acupointsare typically identified by various letter/number combinations, e.g.,L6, S37. The maps that show the location of the acupoints may alsoidentify what condition, illness or deficiency the particular acupointaffects when manipulation of needles inserted at the acupoint isundertaken.

References to the acupoints in the literature are not always consistentwith respect to the format of the letter/number combination. Someacupoints are identified by a name only, e.g., Tongli. The same acupointmay be identified by others by the name followed with a letter/numbercombination placed in parenthesis, e.g., Tongli (HT5). Alternatively,the acupoint may be identified by its letter/number combination followedby its name, e.g., HT5 (Tongli). The first letter(s) typically refers toa body organ, or other tissue location associated with, or affected by,that acupoint. However, usually only the letter(s), not the name of thebody organ or tissue location, is used in referring to the acupoint, butnot always. Thus, for example, the acupoint ST40 is the same as acupointStomach 40 which is the same as ST-40 which is the same as ST 40 whichis the same as Fenglong. For purposes of this patent application, unlessspecifically stated otherwise, all references to acupoints that use thesame name, or the same first letter and the same number, and regardlessof slight differences in second letters and formatting, are intended torefer to the same acupoint.

An excellent reference book that identifies all of the traditionalacupoints within the human body is WHO STANDARD ACUPUNCTURE POINTLOCATIONS IN THE WESTERN PACIFIC REGION, published by the World HealthOrganization (WHO), Western Pacific Region, 2008 (updated and reprinted2009), ISBN 978 92 9061 248 7 (hereafter “WHO Standard Acupuncture PointLocations 2008”). The Table of Contents, Forward (page v-vi) and GeneralGuidelines for Acupuncture Point Locations (pages 1-21), as well aspages 64, 66, 71, 72, 74, 138 and 199 (which illustrate withparticularity the location of acupoints ST36, ST37, ST40, SP4, SP6, SP9,K16 and LRB, respectively, wherein both ST36 and ST37 are shown on page64) of the WHO Standard Acupuncture Point Locations 2008 areincorporated herein by reference.

While many in the scientific and medical community are highly criticalof the historical roots upon which acupuncture has developed, (e.g.,claiming that the existence of meridians, qi, yin and yang, and the likehave no scientific basis), see, e.g.,http://en.wikipedia.org/wiki/Acupuncture, few can refute the vast amountof successful clinical and other data, accumulated over centuries ofacupuncture practice, that shows needle manipulation applied at certainacupoints is quite effective.

The World Health Organization and the United States' National Institutesof Health (NIH) have stated that acupuncture can be effective in thetreatment of neurological conditions and pain. Reports from the USA'sNational Center for Complementary and Alternative Medicine (NCCAM), theAmerican Medical Association (AMA) and various USA government reportshave studied and commented on the efficacy of acupuncture. There isgeneral agreement that acupuncture is safe when administered bywell-trained practitioners using sterile needles, but not on itsefficacy as a medical procedure.

An early critic of acupuncture, Felix Mann, who was the author of thefirst comprehensive English language acupuncture textbook, Acupuncture:The Ancient Chinese Art of Healing, stated that “The traditionalacupuncture points are no more real than the black spots a drunkard seesin front of his eyes.” Mann compared the meridians to the meridians oflongitude used in geography—an imaginary human construct. See, Mann,Felix (2000). Reinventing acupuncture: a new concept of ancientmedicine. Oxford: Butterworth-Heinemann. pp. 14; 31. ISBN 0-7506-4857-0.Mann attempted to combine his medical knowledge with that of Chinesetheory. In spite of his protestations about the theory, however, heapparently believed there must be something to it, because he wasfascinated by it and trained many people in the West with the parts ofit he borrowed. He also wrote many books on this subject. His legacy isthat there is now a college in London and a system of needling that isknown as “Medical Acupuncture”. Today this college trains doctors andWestern medical professionals only.

For purposes of this patent application, the arguments for and againstacupuncture are interesting, but not that relevant. What is important isthat a body of literature exists that identifies several acupointswithin the human body that, rightly or wrongly, have been identified ashaving an influence on, or are otherwise somehow related to, thetreatment of various physiological conditions, deficiencies orillnesses, including obesity and dyslipidemia. With respect to theseacupoints, the facts speak for themselves. Either these points do or donot affect the conditions, deficiencies or illnesses with which theyhave been linked. The problem lies in trying to ascertain what is factfrom what is fiction. This problem is made more difficult whenconducting research on this topic because the insertion of needles, andthe manipulation of the needles once inserted, is more of an art than ascience, and results from such research become highly subjective. Whatis needed is a much more regimented approach for doing acupunctureresearch.

It should also be noted that other medical research, not associated withacupuncture research, has over the years identified nerves and otherlocations throughout a patient's body where the application ofelectrical stimulation produces a beneficial effect for the patient.Indeed, the entire field of neurostimulation deals with identifyinglocations in the body where electrical stimulation can be applied inorder to provide a therapeutic effect for a patient. For purposes ofthis patent application, such known locations within the body aretreated essentially the same as acupoints—they provide a “target”location where electrical stimulation may be applied to achieve abeneficial result, whether that beneficial result is to reducecholesterol or triglyceride levels, to reduce excess body fat, to treatcardiovascular disease, to treat mental illness, or to address someother issue associated with a disease or condition of the patient.

Returning to the discussion regarding acupuncture, some have proposedapplying moderate electrical stimulation at selected acupuncture pointsthrough needles that have been inserted at those points. See, e.g.,http://en.wikipedia.org/wiki/Electroacupuncture. Such electricalstimulation is known as electroacupuncture (EA). According toAcupuncture Today, a trade journal for acupuncturists:“Electroacupuncture is quite similar to traditional acupuncture in thatthe same points are stimulated during treatment. As with traditionalacupuncture, needles are inserted on specific points along the body. Theneedles are then attached using small clips to an external device thatgenerates continuous electric pulses. These devices are used to adjustthe frequency and intensity of the impulse being delivered, depending onthe condition being treated. Electroacupuncture uses two needles at atime so that the impulses can pass from one needle to the other. Severalpairs of needles can be stimulated simultaneously, usually for no morethan 30 minutes at a time.” “Acupuncture Today: Electroacupuncture”.2004 Feb. 1 (retrieved on-line 2006 Aug. 9 athttp://www.acupuncturetoday.com/abc/electroacupuncture.php).

U.S. Pat. No. 6,950,707, issued to Whitehurst et al., discloses use ofan implantable miniature neurostimulator, referred to as a“microstimulator,” that can be implanted into a desired tissue locationand used as a therapy for obesity and eating disorders.

Other patents of Whitehurst et al. teach the use of this small,microstimulator, placed in other body tissue locations, including withinan opening extending through the skull into the brain, for the treatmentof a wide variety of conditions, disorders and diseases. See, e.g., U.S.Pat. No. 6,735,475 (headache and facial pain); U.S. Pat. No. 7,003,352(epilepsy by brain stimulation); U.S. Pat. No. 7,013,177 (pain by brainstimulation); U.S. Pat. No. 7,155,279 (movement disorders throughstimulation of Vagus nerve with both electrical stimulation and drugs);U.S. Pat. No. 7,292,890 (Vagus nerve stimulation); U.S. Pat. No.7,203,548 (cavernous nerve stimulation); U.S. Pat. No. 7,440,806(diabetes by brain stimulation); U.S. Pat. No. 7,610,100(osteoarthritis); and U.S. Pat. No. 7,657,316 (headache by stimulatingmotor cortex of brain).

Techniques for using electrical devices, including external EA devices,for stimulating peripheral nerves and other body locations for treatmentof various maladies are known in the art. See, e.g., U.S. Pat. Nos.4,535,784; 4,566,064; 5,195,517; 5,250,068; 5,251,637; 5,891,181;6,393,324; 6,006,134; 7,171,266; 7,171,266 and 7,373,204. The methodsand devices disclosed in these patents, however, typically utilize (i)large implantable stimulators having long leads that must be tunneledthrough tissue over an extended distance to reach the desiredstimulation site, (ii) external devices that must interface withimplanted electrodes via percutaneous leads or wires passing through theskin, or inefficient and power-consuming wireless transmission schemes.Such devices and methods are still far too invasive, or are ineffective,and thus subject to the same limitations and concerns, as are thepreviously described electrical stimulation devices. From the above, itis seen that there is a need in the art for a less invasive device andtechnique for electroacupuncture stimulation of acupoints that does notrequire the continual use of needles inserted through the skin, or longinsulated wires implanted or inserted into blood vessels, for thepurposes of improving dyslipidemia or reducing excess body fat.

From the above, it is seen that there is a need in the art for a lessinvasive device and technique for electroacupuncture stimulation ofacupoints that does not require the continual use of needles insertedthrough the skin, or long insulated wires implanted or inserted intoblood vessels, for the purposes of improving dyslipidemia or reducingexcess body fat.

SUMMARY

One characterization of the invention described herein is an ImplantableElectroAcupuncture System (IEAS) that treats dyslipidemia and obesitythrough application of electroacupuncture (EA) stimulation pulsesapplied at a specified tissue location(s) of a patient. A key componentof such IEAS is an implantable electroacupuncture (EA) device. The EAdevice has a small, hermetically-sealed housing containing a primarypower source, pulse generation circuitry powered by the primary powersource, and a sensor that wirelessly senses operating commands generatedexternal to the housing. The pulse generation circuitry generatesstimulation pulses in accordance with a specified stimulation regimen ascontrolled, at least in part, by the operating commands sensed throughthe sensor. The EA device further includes a plurality of electrodearrays (where an electrode array comprises an array of n conductivecontacts electrically joined together to function jointly as oneelectrode, where n is an integer) on the outside of the EA devicehousing that are electrically coupled to the pulse generation circuitryon the inside of the EA device housing. Such electrical coupling occursthrough at least one feed-through terminal passing through a wall of thehermetically-sealed housing. Stimulation pulses generated by the pulsegeneration circuitry inside of the EA device housing are directed to theelectrode arrays on the outside of the EA housing. The stimulationpulses are thus applied at the specified tissue location(s) through theplurality of electrode arrays in accordance with the specifiedstimulation regimen. The specified stimulation regimen defines how oftena stimulation session (a stimulation session comprises a stream ofstimulation pulses applied to the specified tissue location(s) over aprescribed period of time) is applied to the patient, and the durationof each stimulation session. Moreover, the stimulation regimen requiresthat the stimulation session be applied at a very low duty cycle. Moreparticularly, if the stimulation session has a duration of T3 minutesand occurs at a rate of once every T4 minutes, then the duty cycle, orthe ratio of T3/T4, cannot be greater than 0.05. The specified tissuelocation(s) whereat EA stimulation pulses are applied comprises at leastone of acupoints ST36, SP4, ST37, ST40, SP6, SP9, KI6 and LR8, orlocation(s) along at least one of their underlying nerves, the peronealand saphenous nerves.

Another characterization of the invention described herein is anImplantable ElectroAcupuncture System (IEAS) for treating dyslipidemiaor obesity. Such IEAS includes (a) an implantable electroacupuncture(EA) device housing having a maximum linear dimension of no more than 25mm in a first plane, and a maximum height of no more 2.5 mm in a secondplane orthogonal to the first plane; (b) a primary battery within the EAdevice housing having an internal impedance of no less than about 5ohms; (c) pulse generation circuitry within the EA device housing andpowered by the primary battery that generates stimulation pulses duringa stimulation session; (d) control circuitry within the EA devicehousing and powered by the primary battery that controls the frequencyof the stimulation sessions to occur no more than once every T4 minutes,and that further controls the duration of each stimulation session tolast no longer than T3 minutes, where the ratio of T3/T4 is no greaterthan 0.05; (e) sensor circuitry within the EA device housing and coupledto the control circuitry that is responsive to the presence of a controlcommand generated external to the EA device housing, which controlcommand when received by the control circuitry sets the times T3 and T4to appropriate values; and (f) a plurality of electrodes located outsideof the EA device housing that are electrically coupled to the pulsegeneration circuitry within the EA device housing. The plurality ofelectrodes are positioned to lie at or near a target tissue location(s)belonging to the group of target tissue locations comprising at leastone of acupoints ST36, SP4, ST37, ST40, SP6, SP9, KI6, LR8, or at leastone location along at least one of their underlying nerves, the peronealand saphenous nerves.

Yet another characterization of the invention described herein is amethod for treating dyslipidemia or obesity in a patient. The methodincludes: (a) implanting an electroacupuncture (EA) device in thepatient below the patient's skin at or near at least one specifiedtarget tissue location; (b) enabling the EA device to generatestimulation sessions at a duty cycle that is less than or equal to 0.05,wherein each stimulation session comprises a series of stimulationpulses, and wherein the duty cycle is the ratio of T3/T4, where T3 isthe duration of each stimulation session, and T4 is the time or durationbetween stimulation sessions; and (c) delivering the stimulation pulsesof each stimulation session to at least one specified target tissuelocation through a plurality of electrode arrays electrically connectedto the EA device. Here, an electrode array comprises an array of nconductive contacts electrically joined together to function jointly asone electrode, where n is an integer. The at least one specified targettissue location at which the stimulation pulses are applied in thismethod is selected from the group of target tissue locations comprisingat least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, KI6, LR8, orat least one location adjacent or along at least one of their underlyingnerves, the peroneal and saphenous nerves.

A further characterization of the invention described herein is a methodof treating dyslipidemia or obesity in a patient using a smallimplantable electroacupuncture device (IEAD). Such IEAD is powered by asmall disc primary battery having a specified nominal output voltage ofabout 3 volts and having an internal impedance of at least 5 ohms. TheIEAD is configured, using electronic circuitry within the IEAD, togenerate stimulation pulses in accordance with a specified stimulationregimen. These stimulation pulses are applied at a selected tissuelocation of the patient through at least two electrodes located outsideof the housing of the IEAD. The method comprises: (a) implanting theIEAD below the skin surface of the patient at or near a target tissuelocation selected from the group of target tissue locations comprisingat least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, KI6, LR8, oralong or near at least one location of their underlying nerves, theperoneal and saphenous nerves; and (b) enabling the IEAD to providestimulation pulses in accordance with a stimulation regimen thatprovides a stimulation session of duration T3 minutes at a rate of onceevery T4 minutes, where the ratio of T3/T4 is no greater than 0.05, andwherein T3 is at least 10 minutes and no greater than 60 minutes.

The invention described herein may additionally be characterized as amethod of assembling an implantable electroacupuncture device (IEAD) ina small, thin, hermetically-sealed, housing having a maximum lineardimension in a first plane of no more than 25 mm and a maximum lineardimension in a second plane orthogonal to the first plane of no morethan 2.5 mm. Such housing has at least one feed-through pin assemblyradially passing through a wall of the thin housing that isolates thefeed-through pin assembly from high temperatures and residual weldstresses that occur when the thin housing is welded shut tohermetically-seal its contents. The IEAD thus assembled is particularlyadapted for use in treating dyslipidemia or obesity of a patient. Themethod of assembling comprises the steps of:

-   -   (a) forming a thin housing having a bottom case and a top cover        plate, the top cover plate being adapted to fit over the bottom        case, the bottom case having a maximum linear dimension of no        more than 25 mm;    -   (b) forming a recess in a wall of the housing;    -   (c) placing a feed-through assembly within the recess so that a        feed-through pin of the feed-through assembly electrically        passes through a wall of the recess at a location that is        separated from where the wall of the housing is designed to        contact the top cover plate; and    -   (d) welding the top cover plate to the bottom case around a        perimeter of the bottom case, thereby hermetically sealing the        bottom case and top case together.

Yet another characterization of the invention described herein is anImplantable ElectroAcupuncture System (IEAS) for treating dyslipidemiaor obesity. Such IEAS includes (a) at least one external component, and(b) a small, thin implantable component having a maximum lineardimension in a first plane of less than 25 mm, and a maximum lineardimension in a second plane orthogonal to the first plan of no more than2.5 mm.

In one preferred embodiment, the external component comprises anelectromagnetic field generator. As used herein, the term“electromagnetic field” encompasses radio frequency fields, magneticfields, light emissions, or combinations thereof.

The implantable component includes a housing made of a bottom part and atop part that are welded together to create an hermetically-sealed,closed container. At least one feed-through terminal passes through aportion of a wall of the top part or bottom part. This terminal allowselectrical connection to be made between the inside of the closedcontainer and a location on the outside of the closed container.Electronic circuitry, including a power source, is included on theinside of the closed container that, when enabled, generates stimulationpulses during a stimulation session that has a duration of T3 minutes.The electronic circuitry also generates a new stimulation session at arate of once every T4 minutes. The ratio of T3/T4, or the duty cycle ofthe stimulation sessions, is maintained at a very low value of nogreater than 0.05. The stimulation pulses are coupled to the at leastone feed-through terminal, where they are connected to a plurality ofelectrodes/arrays located on an outside surface of the closed housing.The stimulation pulses contained in the stimulation sessions are thusmade available to stimulate body tissue in contact with or near theplurality of electrodes/arrays on the outside of the closed housing.

Further included on the inside of the closed container is a sensoradapted to sense the presence or absence of an electromagnetic field.Also included on the inside of the closed container is a power sourcethat provides operating power for the electronic circuitry.

In operation, the external component modulates an electromagnetic fieldwhich, when sensed by the sensor inside of the closed container, conveysinformation to the electronic circuitry inside of the closed housingthat controls when and how long the stimulation sessions are appliedthrough the plurality of electrodes/arrays. Once this information isreceived by the electronic circuitry, the external component can beremoved and the implantable component of the IEAS will carry out thestimulation regimen until the power source is depleted or newinformation is received by the electronic circuitry, whichever occursfirst.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features and advantages of the inventionwill be more apparent from the following more particular descriptionthereof, presented in conjunction with the following drawings. Thesedrawings illustrate various embodiments of the principles describedherein and are part of the specification. The illustrated embodimentsare merely examples and do not limit the scope of the disclosure.

FIGS. 1-17B relate to one preferred embodiment of the invention.

FIGS. 18-31 relate to general principles and concepts associated withthe invention.

FIG. 1 is a perspective view of an Implantable Electroacupuncture Device(IEAD) made in accordance with the teachings presented herein.

FIG. 1A shows with particularity the location of acupoint SP4 orGongsun, one of eight acupoints identified herein for implantation ofthe IEAD for the treatment of dyslipidemia or obesity.

FIG. 1B shows the location of acupoint LR8 or Ququan.

FIG. 1C shows the location of acupoint ST40 or Fenglong.

FIG. 1D shows the location of acupoint SP6 or Sanyinjiao.

FIG. 1E shows the location of acupoint SP9 or Yinlingquan.

FIG. 1F shows the location of acupoint ST36 or Zusanli.

FIG. 1G shows the location of acupoint ST37 or Shangjuxu.

FIG. 1H shows the location of acupoint KI6 or Shuiquan.

FIG. 2 shows a plan view of one surface of the IEAD housing illustratedin FIG. 1.

FIG. 2A shows a side view of the IEAD housing illustrated in FIG. 1.

FIG. 3 shows a plan view of the other side, indicated as the “BackSide,” of the IEAD housing or case illustrated in FIG. 1.

FIG. 3A is a sectional view of the IEAD of FIG. 3 taken along the lineA-A of FIG. 3.

FIG. 4 is a perspective view of the IEAD housing, including afeed-through pin, before the electronic components are placed therein,and before being sealed with a cover plate.

FIG. 4A is a side view of the IEAD housing of FIG. 4.

FIG. 5 is a plan view of the empty IEAD housing shown in FIG. 4.

FIG. 5A depicts a sectional view of the IEAD housing of FIG. 5 takenalong the section line A-A of FIG. 5.

FIG. 5B shows an enlarged view or detail of the portion of FIG. 5A thatis encircled with the line B.

FIG. 6 is a perspective view of an electronic assembly, including abattery, that is adapted to fit inside of the empty housing of FIG. 4and FIG. 5.

FIGS. 6A and 6B show a plan view and side view, respectively, of theelectronic assembly shown in FIG. 6.

FIG. 7 is an exploded view of the IEAD assembly, illustrating itsconstituent parts.

FIG. 7A schematically illustrates a few alternative electrodeconfigurations that may be used with the invention.

FIG. 8A illustrates a functional block diagram of the electroniccircuits used within an IEAD of the type described herein.

FIG. 8B shows a basic boost converter circuit configuration, and is usedto model how the impedance of the battery R_(BAT) can affect itsperformance.

FIG. 9A illustrates a typical voltage and current waveform for thecircuit of FIG. 8 when the battery impedance R_(BAT) is small.

FIG. 9B shows the voltage and current waveform for the circuit of FIG.8B when the battery impedance R_(BAT) is large.

FIG. 10 shows one preferred boost converter circuit and a functionalpulse generation circuit configuration for use within the IEAD.

FIG. 11 shows an alternate boost converter circuit configuration and afunctional pulse generation circuit for use within the IEAD.

FIG. 12 shows a refinement of the circuit configuration of FIG. 11.

FIG. 13A shows one preferred schematic configuration for an implantableelectroacupuncture device (IEAD) that utilizes the boost converterconfiguration shown in FIG. 10.

FIG. 13B shows current and voltage waveforms associated with theoperation of the circuit shown in FIG. 13A.

FIG. 14 shows another preferred schematic configuration for an IEADsimilar to that shown in FIG. 13A, but which uses an alternate outputcircuitry configuration for generating the stimulus pulses.

FIG. 15A shows a timing waveform diagram of representative EAstimulation pulses generated by the IEAD device during a stimulationsession.

FIG. 15B shows a timing waveform diagram of multiple stimulationsessions, and illustrates the waveforms on a more condensed time scale.

FIG. 16 shows a state diagram that shows the various states in which theIEAD may be placed through the use of an external magnet.

FIG. 17A illustrates one technique for implanting an IEAD under the skinin a location where a front surface of the IEAD faces inward toward abone surface of the patient.

FIG. 17B depicts an alternative technique for implanting an IEAD in apocket formed in a bone below a desired acupoint, with a front surfaceof the IEAD facing outward towards the skin.

FIG. 18 is a block diagram that illustrates the two main components ofan Electroacupuncture (EA) Stimulation System made as taught herein.Such EA Stimulation System (also referred to herein as an “EA System”)includes: (1) an External Control Device (ECD); and (2) an ImplantableStimulator (also referred to herein as a “Implantable ElectroacupunctureDevice” or IEAD). Two variations of the IEAD are depicted, either one ofwhich could be used as part of the EA System, one having electrodesformed as an integral part of the IEAD housing, and another having theelectrodes at or near the distal end of a very short lead that isattached to the IEAD.

FIG. 19 is a Table that summarizes the functions performed by the twomain components of the EA System of FIG. 18 in accordance with variousconfigurations of the invention.

FIG. 20 shows the use of one type of electrode integrated within a frontside (the front side is usually—but not always—the side farthest awayfrom the skin when the device is implanted, and thus it is oftenreferred to as the “underneath” side) of a housing structure of animplantable electroacupuncture device, or IEAD. This electrode isinsulated from the other portions of the IEAD housing, which otherportions of the housing structure may function as a return electrode forelectroacupuncture stimulation.

FIG. 20A is a sectional view, taken along the line A-A of FIG. 20, thatshows one embodiment or variation of the IEAD housing wherein theelectrode of FIG. 20 resides in a cavity formed within the front side ofthe IEAD.

FIG. 20B is a sectional view, taken along the line A-A of FIG. 20, andshows an alternative embodiment or variation of the front side of theIEAD housing wherein the electrode comprises a smooth bump thatprotrudes out from the underneath surface of the IEAD a short distance.

FIG. 20C is a sectional view, taken along the line A-A of FIG. 20, andshows yet an additional alternative embodiment or variation of the frontside of the IEAD housing wherein the electrode is at or near the distalend of a short lead that extends out a short distance from the frontside of, or an edge of, the IEAD housing.

FIG. 21 is similar to FIG. 20, but shows the use of an electrode arrayhaving four individual electrodes integrated within the housingstructure of an IEAD.

FIG. 21A is a sectional view, taken along the line B-B of FIG. 21, thatshows an embodiment where the electrodes comprise rounded bumps thatprotrude out from the front surface of the IEAD a very short distance.

FIG. 21B is likewise a sectional view, taken along the line B-B of FIG.21, that shows an alternative embodiment or variation where theelectrodes comprise tapering cones or inverted-pyramid shaped electrodesthat protrude out from the front surface of the IEAD a short distanceand end in a sharp tip, much like a needle.

FIG. 21C is a also a sectional view, taken along the line B-B of FIG.21, that shows yet another embodiment or variation of the front surfaceof the IEAD housing where the electrodes comprise small conductive padsformed at or near the distal end of a flex circuit cable (shown twisted90 degrees in FIG. 21C) that extends out from the front surface of theIEAD housing a short distance.

FIGS. 22A through 22E show various alternate shapes of the housing ofthe IEAD that may be used with an EA System. Each respective figure,FIG. 22A, FIG. 22B, FIG. 22C, and FIG. 22D show side sectional views ofthe housing shape, and FIG. 22E shows both a perspective view (labeledas “A”) and a side view (labeled as “B”) of the housing shape.

FIG. 23 is an electrical functional block diagram of the circuitry andelectrical components housed within an EA System which includes an IEADand External Controller in accordance with the various embodiments ofthe invention. The functional circuitry shown to the right of FIG. 23 iswhat is typically housed within the IEAD. The functional circuitry shownto the left of FIG. 23 is what is typically housed within the ExternalController. How much circuitry is housed within the IEAD and how much ishoused within the External Controller is a function of which embodimentof the EA System is being used.

FIG. 24 is an electrical functional block diagram of a passive IEAD(where “passive”, as used herein, means a circuit that generally employsonly wires or conductors, capacitors, or resistors, and requires nointernal power source). This passive IEAD is intended for use withEmbodiment III (FIG. 18).

FIG. 25A is an electrical functional block diagram of a voltagestimulation output stage that may be used within the IEAD (right side ofFIG. 23).

FIG. 25B is an electrical functional block diagram of a currentstimulation output stage that may be used within the IEAD (right side ofFIG. 23) instead of the voltage stimulation output state of FIG. 25A.

FIG. 26 illustrates one embodiment of a power source that may be usedwithin the IEAD which utilizes both a supercapacitor and a rechargeablebattery.

FIG. 27 is a timing diagram that illustrates a typical stimulationpattern of biphasic stimulation pulses used by the EA System, anddefines some of the operating parameters that may be programmed as partof the programmed stimulation regime.

FIG. 28 is likewise a timing diagram that illustrates, on a larger timescale than FIG. 27, various stimulation patterns and operatingparameters that may be programmed for use by the EA System.

FIG. 29 is a flowchart that illustrates a typical EA stimulation processor method for use with the EA stimulation system described herein.

FIG. 30 is a flowchart that illustrates a manually triggered EAstimulation process or method for use with the EA stimulation systemdescribed herein.

FIG. 31 is an alternate flowchart that illustrates anotherrepresentative EA stimulation process or method that may be used withsome embodiments of the IEAD described herein.

Appendix A, found in Applicant's previously-filed patent applicationSer. No. 13/622,497, filed Sep. 19, 2012 (hereafter Applicant's “Parentapplication”), incorporated herein by reference, illustrates someexamples of alternate symmetrical electrode configurations that may beused with an IEAD of the type described herein.

Appendix B, also found in Applicant's Parent Application, illustrates afew examples of non-symmetrical electrode configurations that may beused with an IEAD made in accordance with the teachings herein.

Appendix C, likewise found in Applicant's Parent Application, shows anexample of the code used in the micro-controller IC (e.g., U2 in FIG.14) to control the basic operation and programming of the IEAD, e.g., toTurn the IEAD ON/OFF, adjust the amplitude of the stimulus pulse, andthe like, using only an external magnet as an external communicationelement.

Appendix D, found in Applicant's Parent Application, contains selectedpages from the WHO Standard Acupuncture Point Locations 2008 referencebook.

Appendix E, found in Applicant's Parent Application, shows alternatecase shapes and electrode placements for an implantable EA device of thetype disclosed herein.

Appendix F, found in Applicant's Parent Application, illustratesalternate approaches for use with a short pigtail lead attached to thehousing of the EA stimulation device.

Appendices A, B, C, D, E and F are incorporated by reference herein.

Throughout the drawings and appendices, identical reference numbersdesignate similar, but not necessarily identical, elements.

DETAILED DESCRIPTION Overview

Disclosed and claimed herein is a small electroacupuncture (EA) device,having one or more electrodes formed within and as an integral part of,or anchored to, its housing. The EA device disclosed herein is adaptedto be treat obesity and dyslipidemia. It is implanted through a smallincision, e.g., less than 2-3 cm in length, directly adjacent to aselected acupuncture site, or other specified target tissue stimulationsite, known to moderate or affect a patient's physiological or healthcondition that needs treatment. In accordance with the teachings herein,the small EA device is implanted so that its electrodes are located at,or near, a desired target tissue location, e.g., at a target acupuncturesite. (An acupuncture site may also be referred to herein as an“acupoint.”)

Once the electrode(s) are anchored at the selected target stimulationsite, electrical stimulation is applied using a low intensity, lowfrequency and low duty cycle stimulation regime that is designed toachieve the same or similar beneficial therapeutic effects as havepreviously been obtained through conventional acupuncture treatments ornerve stimulations. One of the primary advantages and benefits providedby the EA device disclosed herein (used to electrically stimulateacupoints) is that an entire body of medicine (acupuncture, as developedand matured over thousands of years) may be brought to the generalpopulace with a much more uniform approach than has heretofore beenachievable.

As used herein, the term “EA device” may refer to either a smallImplantable NeuroStimulator (INS) designed for stimulating nerves and/orother body tissue at a precisely-defined location; or a smallimplantable electroacupuncture (EA) device, or “IEAD”, designed tostimulate an acupuncture site, or acupoint, where an “acupoint” isinherently defined as a precise tissue location. Thus, as used herein,IEAD=EA device=implanted neurostimulator=INS. And, as used herein,acupoint=an acupuncture stimulation point=a target tissue/nervestimulation location where electrical pulses generated by aneurostimulator device, i.e., an EA device, are applied.

Also, as used herein, “electrode” and ‘electrode contact” or“electrodes” and “electrode contacts” or electrode array, are often usedinterchangeably to refer to that part of the EA device housing, or thatpart of a lead connected to an EA or INS device, from which electricalstimulation pulses, currents and/or voltages are applied to body tissue.

Applying the EA stimulation according to a prescribed stimulation regimeis an important key of the invention because it allows a more uniformhealth care approach to be followed for treatment of a particulardisorder or illness. Conventional acupuncture treatment, on the otherhand, relies heavily on the skill and experience of the acupuncturist,which may vary a great deal from acupuncturist to acupuncturist. Incontrast, electroacupuncture treatment as taught herein may be uniformlyapplied for a specific disorder or illness once the electrodes arepositioned at or near the correct acupoint, or other tissue locationknown to affect a condition being treated, and once the prescribedstimulation regime is shown to be effective.

Applying the EA stimulation at low intensities, low frequencies and lowduty cycles is also a key feature of the invention because it allows thepower source of the EA device to be small, yet still with sufficientcapacity to uniformly carry out the stimulation procedure (orstimulation regime) for several years, thereby reducing the amount oftime a patient has to spend at the office of medical personnel who aremonitoring or otherwise overseeing the patient's treatment.

Further, having the EA device be small, with the electrodes an integralpart of the housing of the device, or in very close proximity of thedevice at the distal end of a very short lead, overcomes the limitationsof having to use a large pulse generator implanted in the trunk of thepatient's body and thereafter having an insulated lead wire tunneledthrough the limbs to an acupuncture point. (It is noted that the use ofa large pulse generator in the body's trunk, with long leads tunneledthrough tissue or blood vessels to the needed acupoint is the currentstate of the art in implanted electroacupuncture art, as evidenced,e.g., in U.S. Pat. No. 7,373,204).

A preferred EA device made in accordance with the teachings of theinvention is thus small, and has a mechanical shape or envelope thatmakes it easy to implant through a small incision made near or at thetarget stimulation site, e.g., the selected acupuncture site. The EAdevice may be configured in various shapes. One shape that may be usedis configured in disk form, with a diameter of 2 to 3 cm, and athickness of 2-4 mm. Other shapes that could be used include egg-shaped,spherical or semi-spherical, rectangular with rounded corners,key-shaped, and the like. Whatever the shape, once the EA device isimplanted, the housing of the EA device, with its particular shape,helps anchor the device, and more importantly helps anchor itselectrodes, in their desired position at or near the target acupoint (orother target stimulation site) that is to be stimulated.

A preferred application for an EA device made in accordance with theteachings presented herein is to treat dyslipidemia or obesity. Thus,the description that follows describes in much more detail an EA devicethat is especially suited to be used to treat dyslipidemia or obesity.However, it is to be understood that the invention is not limited totreating dyslipidemia or obesity. For example, the EA device describedherein may be used to treat any of the diseases and conditions describedin described in Cheung, Mechanism of Acupuncture, 2001, which isincorporated herein by reference as explained above. For example, asdescribed in Cheung, Mechanism of Acupuncture, 2001, stimulation may beapplied to the tibial nerve (e.g., by stimulating acupoint SP6) to treata genitourinary disease (e.g., urinary bladder dysfunction and/or adisease involving the micturition reflex). As explained in more detailbelow, the essence of the invention recognizes that anelectroacupuncture modulation scheme need not be continuous, therebyallowing the implanted EA device to use a small, high density, powersource to provide such non-continuous EA modulation. (It should be notedthat “EA modulation,” as that phrase is used herein, is the applicationof electrical stimulation pulses, at low intensities, low frequenciesand low duty cycles, to at least one of the acupuncture sites that hasbeen identified as affecting a particular illness, deficiency, disorderor condition.) As a result, the EA device can be very small. And,because the electrodes form an integral part of the housing of the EAdevice, or are connected thereto through a very short lead, the EAdevice may thus be implanted directly at (or very near to) the desiredtarget tissue location, e.g., the target acupoint. Hence, any conditionof a patient that has heretofore been successfully treated throughconventional acupuncture treatments is a potential candidate fortreatment with the EA device described herein.

Modulation (i.e., EA stimulation) regimens, of course, are tailored tothe specific illness, condition, disorder or deficiency being treated,but the same basic approach may be followed as is taught herein forwhatever acupoint, or target tissue site, is to be modulated. Insummary, and as explained more fully below in conjunction with thedescription of the treatment of dyslipidemia or obesity, the basicapproach of EA stimulation includes: (1) identify an acupoint(s) (orother specific target stimulation site) that may be used to treat ormediate the particular illness, condition or deficiency that hasmanifest itself in the patient; (2) implant an EA device, made asdescribed herein, so that its electrodes are firmly anchored and locatedso as to be near or on the identified acupoint(s) or target site(s); (3)apply EA modulation, having a low intensity, low frequency, and low dutycycle through the electrode(s) of the EA device so that electricalstimulation pulses flow through the tissue at the target acupoint(s), orother target site(s), following a prescribed stimulation regimen overseveral weeks or months or years. At any time during this EA stimulationregimen, the patient's illness, condition or deficiency may be evaluatedand, as necessary, the parameters of the EA modulation applied duringthe EA stimulation regimen may be adjusted or “tweaked” in order toimprove the results obtained from the EA modulation.

Conditions Treated

Dyslipidemia is defined as an abnormal plasma lipid profile. The mostcommon dyslipidemias are high total cholesterol, LDL cholesterol, Lp(a),and triglycerides; low levels of high-density lipoprotein (HDL)cholesterol; and high levels of small dense LDL particles. Theseabnormal lipid conditions can be found alone or in combination.

Cholesterol levels are measured in milligrams (mg) of cholesterol perdeciliter (dL) of blood. Guidelines exist that provide preferred lipidlevels. The ideal total cholesterol level is under 200 mg/dL; normalfalls between 160 and 240 mg/dL. Preferred LDL cholesterol is below 70mg/dL for persons at very high risk of heart disease, and below 100mg/dL for persons at risk of heart disease. Normal is between 90 and 171mg/dL. HDL should preferably be at 60 mg/dL and above or between 35 and80 mg/dL. Last, triglycerides should be below 150 mg/dL.

Obesity is associated with dyslipidemia, most often in the form of highcholesterol. Obesity may lead to high cholesterol.

Obesity is defined as having an excessive amount of body fat, which isdiagnosed by the Body Mass Index—a calculation of one's weight inrelationship to one's height. A BMI of 30 or above generally signifiesobesity while a BMI between 25 and 29 is considered overweight. A stateof being overweight is also cause for concern given the serious riskfactors associated with the overweight state and with further weightgain.

It should be understood that an “overweight condition” includes obesity.While an overweight person is not necessarily obese, an obese person isoverweight.

The present invention is intended to treat obesity or dyslipidemia orboth.

Applicant has determined that some overlap exists in acupoint selectionfor successful treatment of both (1) obesity and (2) dyslipidemias. Inparticular, the primary acupoint utilized with success to treatdyslipidemia is one identified by Applicant for reduction of body fat.Applicant believes that the efficacy in acupuncture studies fortreatment of these two conditions arises from the unique location ofacupoints and the nerves underlying those points. Thus, Applicantidentifies more than one acupoint for the treatment of these conditionsbased upon various studies pointing to certain acupoints and a deductionthat certain nerves underlying those acupoints are central to themechanism. Those nerves are the saphenous and peroneal nerves. Theacupoints are ST36, SP4, ST37, ST40, SP6, SP9, KI6, and LR8. Theinvention thus applies EA stimulation to at least one target tissuestimulation site that includes acupoints ST36, SP4, ST37, ST40, SP6,SP9, KI6, and LR8, and/or a point at or near the saphenous and peronealnerves.

Applicant outlines in the paragraphs below the more compelling orimportant work that supports its identification of the above acupointsand their underlying nerves.

Among the most compelling studies are several conducted by Cabioglu etal in Turkey. Cabioglu et al conducted six studies utilizingelectroacupuncture at various acupoints, including four constantacupoints. See, Cabioglu, M. T. and N. Ergene. Electroacupuncturetherapy for weight loss reduces serum total cholesterol, triglycerides,and LDL cholesterol levels in obese women. Am. J. Chin. Med. 33(4):525-533,2005 (hereafter, “Cabioglu 2005”); Cabioglu, M. T. and N.Ergene. Changes in serum leptin and beta endorphin levels with weightloss by electroacupuncture and diet restriction in obesity treatment.Am. J. Chin. Med. 34: 1-11, 2006; Cabioğlu MT, Ergene N, Tan U.Electroacupuncture Treatment of Obesity with Psychological Symptoms.Int. J. Neurosci 2007; 117: 579-90 (hereafter, Cabioglu 2007″);Cabioglu, M. T., Ergene, N., Surucu, H. S., celik, H. H., & Findik, D.(2007). Serum IgG, IgA, IgM, and IgE levels after electroacupuncture anddiet therapy in obese women. The American journal of Chinese medicine,35(06), 955-965 (hereafter, “Cabioglu et al 2007”); Cabioğlu, M. T., &Ergene, N. (2006). Changes in levels of serum insulin, C-peptide andglucose after electroacupuncture and diet therapy in obese women. TheAmerican journal of Chinese medicine, 34(03), 367-376 (hereafter,“Cabioğlu, Ergene 2006); The Efficacy of Electroacupuncture Therapy forWeight Loss changes Plasma Lipoprotein A, Apoliprotein A andApoliprotein B Levels in Obese Women. 2008. The American Journal ofChinese Medicine; 36 (06):1029-1039 (hereafter, “Cabioglu 2008”).

In all of Cabioglu's studies, two acupoints were utilized which overliethe saphenous and peroneal nerves: ST36 and ST44. In addition, two ofthe four points always utilized in the Cabioglu studies are not commonlyincluded (or their primary underlying nerve) in other acupuncturestudies bringing about weight loss in overweight patients. See, e.g.,Cheng Ling, Chen Miao-gen, YANG Hui, et al. Influence of Acupuncture onInsulin Resistance in Simple Obesity Patients. J of Acupunct Tuina Sci;2007, 5(4): 245-249 (hereafter, “Cheng 2007”). Those points are LI4 andLI11. Thus, acupoints LI4 and LI11 are excluded from the stimulationsites utilized by the present invention. Additionally, because ST44 isnot practical for the technological approach used by the invention, ST44has been omitted from the points of stimulation called for by theinvention.

For other studies showing weight loss with the use of ST36, see also,Zhao, N. X., Guo, R. L., & Ren, Q. Y. (2004). Effect of AcupunctureTreatment on Cellular Hemorheology, Cholesterol and Triglyceride ofSimple Obesity Patients. WORLD JOURNAL OF ACUPUNCTUREMOXIBUSTION-BEIJING-,14(3), 24-27 (hereafter, “Zhao 2004”); Qunli W,Zhicheng L. Acupuncture treatment of simple obesity. J Tradit Chin Med2005(2):90-4 (hereafter, “Qunli 2005”); Li-qiu L, Wei-zhi G, Xin D.Treatment of Simple Obesity of Stomach-Intestine Excessive Heat Type byAcupuncture and Tuina. J Acupunct Tuina Sci; 2005; 3(2):61-62(hereafter, Li-qiu 2005″); Güçel, F., Bahar, B., Demirtas, C., Mit, S.,çcevik, C. (2012). Influence of acupuncture on leptin, ghrelin, insulinand cholecystokinin in obese women: a randomised, sham-controlledpreliminary trial. Acupuncture in Medicine, 30(3), 203-207 (hereafter,“Gucel 2012”); Liu, Z. C., Wang, Y. Z., Hu, K., Li, J., Shi, X. B., &Sun, F. M. (1995). Good regulation of acupuncture in simple obesitypatients with stomach-intestine excessive heat type. Chinese Journal ofIntegrative Medicine, 1(4), 267-271 (hereafter, “Liu 1995”); Cheng 2007.

In a study called “Study on the Effect of Transcutaneous Electric NerveStimulation on Obesity,” sixteen patients underwent transcutaneouselectric nerve stimulation (“TENS”) on five acupoints and achievedweight loss. See, Tian D R, Li X D, Shi Y S et al (2003) Study on theeffect of transcutaneous electric nerve stimulation on obesity. J PekingUniv (Health Sci) 35:277-279. English Translation (hereafter, “Tian2003”). Those five acupoints include one of the chosen points, SP4,selected by Applicant for use with its invention. Patients lost about3.9% of their baseline weight of 72 kilograms on average. From ananalysis of many obesity studies, Applicant has come to the conclusionthat those acupoints overlying the saphenous and the peroneal nerve aremost active in bringing about weight loss. In the Tian study, the onlyacupoint overlying one of those nerves, the saphenous nerve, is SP4.

In another study for which manual acupuncture was utilized in obesepatients with success, four points were manually stimulated with anacupuncture needle. See, Qunli 2005. The four acupoints were BL18, LR8,GB43, and LR3. Applicant believes acupoints LR8 and LR3 are mostresponsible for the weight loss achieved in this study. Given that theacupoint LR8 is better situated for an implantation of a coin-sizeddevice, Applicant has excluded acupoint LR3 from the selected targetstimulation sites utilized by this invention. In this study documentedin Qunli 2005, 5.2% weight loss was achieved in five people over twentyfour days or twelve treatment days.

Furthermore, in six of the studies Applicant considers efficacious inthe use of acupuncture for the treatment of obesity, one acupoint, ST40,is utilized in addition to several other points. See, e.g. Tian 2003;Qunli 2005; Li L, Wang Z Y. Clinical therapeutic effects of bodyacupuncture and ear acupuncture on juvenile simple obesity and effectson metabolism of blood lipids. Zhongguo Zhen Jiu; 2006; 26(3):173-6.English Translation (hereafter, “Li 2006”); Zhan M, Wang H. Observationon therapeutic effects of electroacupuncture for obesity polycysticovary syndrome. J Acupunct Tuina Sci; 2008; 6(2):90-93 (hereafter, “Zhan2008”); Li-qiu 2005; Cheng 2007.

In particular, the efficacy was notable in a study conducted by Cheng etal. for which ten acupoints were manually stimulated in fifty obesepatients. See, Cheng 2007. Low-frequency electroacupuncture was alsoutilized at three of the acupoints claimed in the present invention(i.e., ST36, ST40, and SP6) alongside a few other acupoints and eracupoints as is common. Over about 15 treatment days, patients lostabout 4.5% of their baseline weight.

For efficacious acupuncture work utilizing ST37, SP6, SP9, and KI6, see,Qunli 2005. In Qunli's study, four different groups were given manualacupuncture at four to six acupoints. Each group showed reductions inbody weight and each group utilized at least one point(s) overlying oneof the saphenous or peroneal nerves. See also, Li-qiu 2005.

In addition to the effect on weight loss, there exists evidenceutilizing acupuncture at these points or similar acupoints to bringabout improvements to a patient's lipid profile. For example, in twodifferent studies, over one hundred patients in each study were treatedwith acupuncture at ST40 and showed improvements in cholesterol andtriglyceride levels. See, Xie, J. P., Liu, G. L., Qiao, J. L., Gu, Q.,Gai, Y. N., Huang, S. F., . . . & Jia, J. J. (2009). Multi-centralrandomized controlled study on electroacupuncture at Fenglong (ST 40)for regulating blood lipids. Chin Acupunc Moxibustion, 29, 345-348.Chinese with English Translation (hereafter, “Xie 2009”); See also,Zhang, T. F., Wan, W. J., Zhang, H. X., Li, J. W., Cai, G. W., & Zhou,L. (2006). Multi-center observation of electroacupuncture at Fenglongpoint in the treatment of hyperlipidemia. English abstract (hereafter,“Zhang 2006”).

In addition to acupoint ST40, several other acupoints overlying thesaphenous or peroneal nerves have been associated with improvements inlipid status. See, e.g. Cabioglu 2005; Li, L., & Wang, Z. Y. (2006).Clinical therapeutic effects of body acupuncture and ear acupuncture onjuvenile simple obesity and effects on metabolism of blood lipids].Zhongguo zhen jiu=Chinese acupuncture & moxibustion, 26(3), 173(hereafter, “Li, Wang 2006”); Li-qiu 2005; Cheng 2007. Thus, Applicanthas identified other acupoints overlying the believed active nerves thatmay effectively improve lipids. In particular, Applicant has identifiedtarget stimulation sites that have at least been successful at reducingbody fat as previously mentioned.

Acupuncture for the reduction of body fat has been shown to involvecertain hormones such as leptin, ghrelin, cholecystokinin, and betaendorphin. See, e.g. Cabioglu 2006; Gucel 2012. In Cabioglu's study andanother by Gucel, weight loss was accompanied by reductions in leptin.Because leptin is thought to be involved in stimulating appetite,acupuncture too appears to be involved in acting on the appetite.

Furthermore, Gucel's study demonstrated increases in plasma ghrelin andCholecystokinin (CCK) levels in subjects who received acupuncturetreatment. See, Gucel 2012. CCK is a neurotransmitter causing satietyafter a meal by affecting the central nervous system, and hence it has aclose relationship with ghrelin. CCK secretion has been shown todecrease hunger. An increase of ghrelin, on the other hand, is known toincrease appetite and bring about weight gain. Thus, the increase inghrelin in Gucel's study is not reconciled with the results of weightloss.

In addition to the hormones associated with changes in weight, one studyutilizing an effective acupoint for weight loss and achievingimprovements in cholesterol also showed the peroneal nerve must beinvolved in the cholesterol changes. See, Wu, C. C., & Hsu, C. J.(1979). Neurogenic regulation of lipid metabolism in the rabbit—Amechanism for the cholesterol-lowering effect of acupuncture.Atherosclerosis, 33(2), 153-164 (hereafter, Wu 1979). In thoseexperiments, only one acupoint, LR3 or “Taichong,” was stimulated,sometimes unilaterally and sometimes bilaterally. In two of theexperiments, the deep peroneal nerve was dissected and in both of thoseexperiments the rabbits with dissection did poorer in modulation ofcholesterol than those with intact deep peroneal nerves. In anotherexperiment, “experiment three,” serum cholesterol leveles weresignificantly lowered 1-3 weeks after acupuncture in the acupuncturegroup than in either the control group or the blocked acupuncture group.“Blocked acupuncture” entailed the injection of 1% novacainintramuscularly at one side of the acupoint LR3, intended to block thesensory nerve receptors followed by needling of that same point.

Thus, it appears there may be hormonal influences on the weight lossachieved through acupuncture at certain points, and the peroneal nervemay be central to the cholesterol changes and possibly reductions inbody fat.

Locations Stimulated and Stimulation Paradigms/Regimens

Applicant has identified a group of acupoints expected to both reducebody fat and improve the lipid profile when stimulated as taught herein.Those acupoints are: ST36, SP4, ST37, ST40, SP6, SP9, KI6, and LR8. Inaddition, the nerves underlying these acupoints—the peroneal andsaphenous nerves—are thought by Applicant to be central to an acupoint'seffectiveness in reducing body fat and improving the lipid profile.Hence, these underlying nerves are also identified as effective targettissue stimulation site(s) when stimulated as taught herein.

Note, for each acupoint, it is possible another similarly butdifferently spelled name may be used by some to identify the sameacupoint. Given the breadth of acupuncture practice across the world,there are a number of letter combinations that often point to the sameacupoint. For the purpose of simplicity, this application will eitherrefer to the two letter merdian and associated number, e.g. ST36, or tothe written name it finds most commonly used, e.g. Zusanli.

The acupoint ST36, also called “Zusanli,” is located on the anterioraspect of the leg, in the fossa one finger breadth lateral to theanterior margin of the tibia. See, WHO Standard Acupuncture PointLocations 2008, page 64. See also FIG. 1F. It may be identified as ST36or Zusanli, Shousanli, or Tsusanli; each name refers to the sameacupoint.

The acupoint SP4, also called “Gongsun,” is located on the medial sideof the foot when in a seated position, in the fossa distal and inferiorto the base of the first metatarsal. See, WHO Standard Acupuncture PointLocations 2008, page 71. See also FIG. 1A. SP4 is located in thedepression distal to the base of the first metatarsal bone.

The acupoint ST37, also called “Shangjuxu,” is located on the anterioraspect of the leg, approximately six B-cun below the knee, in the fossaone finger width lateral to the tibia on the tibialis anterior musclebetween the tibia and fibula. It is also three B-cun below ST36. (Note,the measurement “B-cun” is a proportional skeletal (bone) measurementsystem, and is explained further below.) See, WHO Standard AcupuncturePoint Locations 2008, page 64. See also FIG. 1G. ST37 is less frequentlycalled “Shangchuchu.”

The acupoint ST40, also called “Fenglong,” is located on theanterolateral aspect of the leg, at the lateral border of the tibialisanterior muscle, about 8 B-cun superior to the prominence of the lateralmalleolus. See, WHO Standard Acupuncture Point Locations 2008, page 66.See also FIG. 1C. (Note: “8 B-cun” is a proportional bone (skeletal)measurement, and is explained in WHO Standard Acupuncture PointLocations 2008, pages 11-13, previously included in the materialincorporated herein by reference.) ST40 is also identified as about onefingerbreadth (a middle finger) lateral to its neighboring point, ST38.It is called ST40, ST 40, Stomach 40, Fenglong, among other names; eachname refers to the same acupoint. Herein, Applicant identifies thisacupoint as ST40 or Fenglong.

The acupoint SP6, or “Sanyinjiao,” is located, when in a seatedposition, approximately 3 B-cun (see previous paragraph for adescription of the “B-cun” proportional bone measurement system; note: 3B-cun is typically about 3 inches for an adult of average size) or fourfinger widths above the medial malleolus, and in the fossa posterior tothe medial margin of the tibia. See, WHO Standard Acupuncture PointLocations 2008, page 72. See also FIG. 1D.

The acupoint SP9, or “Yinlinquan,” is located on the medial side of theknee, in the fossa inferior to the medial condyle of the tibia, at thesame height as the inferior margin of the tibial tuberosity, at theinsertion of the artorius muscle. See, WHO Standard Acupuncture PointLocations 2008, page 74. See also FIG. 1E.

The acupoint KI6, or “Zhaohai.” is located in the efossa below themedial malleolus of the tibia, between the medial malleolus and thetalus. See, WHO Standard Acupuncture Point Locations 2008, page 138. Seealso FIG. 1H.

The acupoint LR8, also called “Ququan,” is located on the medial aspectof the knee, in the depression medial to the tendons of thesemitendinosus and the semimenbranosus muscles, at the medial end of thepopliteal crease. See, WHO Standard Acupuncture Point Locations 2008,page 199. See also FIG. 1B. With the knee flexed, LR8 is located in thedepression medial to the most prominent tendon on the medial end of thepopliteal crease. The acupoint may be identified as LR8, Liv 8, LR 8,Liver 8, or Ququan; each name refers to the same point. Herein,Applicant identifies this point as LR8 or Ququan.

High-frequency stimulation is less successful at bringing about weightloss in overweight patients when compared to low-frequency stimulationparadigms that are otherwise similar in acupoint selection orstimulation paradigm. See, e.g. Lin, C. H., Lin, Y. M., & Liu, C. F.(2010). Electrical acupoint stimulation changes body composition and themeridian systems in postmenopausal women with obesity. The AmericanJournal of Chinese Medicine, 38(04), 683-694 (hereafter, “Lin 2010”);Hsu, C. H., Hwang, K. C., Chao, C. L., Lin, J. G., Kao, S. T., & Chou,P. (2005). Effects of electroacupuncture in reducing weight and waistcircumference in obese women: a randomized crossover trial.International journal of obesity, 29(11), 1379-1384 (hereafter, “Hsu2005”); Rerksuppaphol, L., & Rerksuppaphol, S. (2011). Efficacy ofelectro-acupuncture at the main acupoints for weight reduction in Thaiobese women (hereafter, “Rerksuppaphol 2011”).

Applicant has identified a frequency range as low as 2 Hz and as high as15 Hz for the ideal stimulation paradigm in this application. Thisfrequency selection is based upon the paradigm used by Cabioglu's groupin its six studies, by a transcutaneous electric nerve stimulation studypreviously mentioned, and by the successful use of manual acupuncturefor bringing about weight loss. See e.g., Cabioglu 2008; Cabioglu 2006;Cabioglu, Ergene 2006; Cabioglu 2005; Cabioglu et al 2007; Cabioglu2007; Tian, D., Li, X., Shi, Y., Liu, Y., & Han, J. (2003). Study on theeffect of transcutaneous electric nerve stimulation on obesity. Beijingda xue xue bao. Yi xue ban=Journal of Peking University. Healthsciences, 35(3), 277. Chinese with English Translation (hereafter, “Tian2003”); Güçel, F., Bahar, B., Demirtas, C., Mit, S., çcevik, C. (2012).Influence of acupuncture on leptin, ghrelin, insulin and cholecystokininin obese women: a randomised, sham-controlled preliminary trial.Acupuncture in Medicine, 30(3), 203-207 (hereafter, “Gucel 2012”).

In addition, in one of Cabioglu's studies utilizing low-frequencystimulation, the lipid profile was positively affected. See, Cabioglu2005.

Stimulation utilizing low current or low intensity appears successful atbringing about weight loss when applied to a specified acupoint mostlikely because of little resistance at those acupoints. Applicant hasidentified a suitable intensity of between one and ten milliamps to usefor purposes of providing EA stimulation as taught herein based upon itsanalysis of the current used in successful electroacupuncture studies.It does not appear a high intensity stimulation is required, exceptperhaps with the use of transcutaneous electric nerve stimulationwherein the skin must also be penetrated by electrical current. Inaddition, manual acupuncture, which is not thought to be as intense asis high intensity electroacupuncture, has had a fair amount of success.See, e.g. Gucel 2012, Cheng 2007, Zhi-Cheng, L., Feng-min, S., &Yi-zheng, W. (1995). Good Regulation of Acupuncture in Simple ObesityPatients with Stomach-Intestine Excessive Heat Type [J]. CHINESE JOURNALOF INTEGRATED TRADITIONAL AND WESTERN MEDICINE, 3 (hereafter, “Zhi-cheng1995”); Li-qiu 2005; Qunli 2005; Zhao 2004. Because low currentstimulation is more ideal when a small battery size is used (which isthe case for Applicant's invention(s) described herein), and furtherbecause both manual acupuncture and EA stimulation using low currenthave proven successful, Applicant has limited its stimulation paradigmfor use with its device to a low current, in addition to a low frequency(low duty cycle) stimulation paradigm.

Applicant has identified a pulse-width range of about one halfmillisecond, or 0.5 ms. While the Cabioglu studies utilized a narrowerpulse width, Applicant understands that such a narrow pulse width of0.05 ms may prove more difficult in the recruitment of fibers. Thechosen pulse width is in line with one study done by Tian et al. See,Tian 2003.

The 2000 year history of acupuncture supports a fairly short stimulationsession duration and rate of occurrence. It supports a rate ofoccurrence of the stimulation session as short as once a day, and astimulation session duration as short as 10-20 minutes (though moreordinarily done in 30 minute durations). However, it also supports arate of occurrence as long as once every other week (though morefrequently once a week), with a stimulation session duration as long as60 minutes. Applicant believes the science of acupuncture has thusidentified the most ideal duration and rate of occurrence for both thelife of the device and for beneficial patient results. Accordingly,Applicant has chosen a stimulation session duration of between about 10minutes and about 60 minutes with a rate of occurrence of thestimulation sessions between once daily to once every other week.

I. General Principles and Concepts

An exemplary EA System 10 will next be described in connection withFIGS. 18-31. First, with respect to FIG. 18 (and subsequently withrespect to other figures which show, and the accompanying descriptiondescribes, more details and features associated with the EA System 10)there is shown a perspective view of an exemplary EA System. As hasalready been indicated, a preferred application of the EA System is totreat dyslipidemia or obesity. But, as has also previously beenindicated, the EA System has applicability to treating other conditions,illnesses, disorders and deficiencies other than just dyslipidemia orobesity. The scope of the invention should be ascertained from theclaims.

As seen in FIG. 18, the EA System 10 includes two main components: (1)an External Control Device (ECD) 20 and (2) an ImplantableElectroAcupuncture Device 30, or IEAD 30. (It is noted that in SectionII below, the IEAD is also referred to using the reference numeral 100.Thus, whether it is referred to as the IEAD 30 or the IEAD 100, it isessentially the same or a similar element.) Two versions of the ECD 20are included in FIG. 18. A first is a hand-held electronic device thatincludes a port 211 enabling it to be coupled to a computer, or similarprocessor. A second is a magnet, typically a cylindrical magnet. Twoversions of an IEAD are also included in FIG. 18, either one of whichmay be used. One embodiment (top right of FIG. 17) has an electrode 32that forms an integral part of the case 31 of the IEAD 30; and the otherembodiment (lower right of FIG. 1A) has an electrode 32 that is locatedat the end of a short lead 41 attached to the IEAD 30.

The IEAD 30, in one embodiment, is disc shaped, having a diameter ofabout 2 to 3 cm, and a thickness of about 2 to 4 mm. It is implantedjust under the skin 12 of a patient near a desired acupuncture site.Other shapes and sizes for the IEAD 30 may also be used, as described inmore detail below. The desired acupuncture site is also referred toherein as a desired or target “acupoint.” For dyslipidemia or obesity,the desired site is at least one of acupoints ST36, SP4, ST37, ST40,SP6, SP9, KI6, LRB, or certain underlying nerves, e.g., the peroneal andsaphenous nerves.

The IEAD 30 includes an electrode 32 which may take various forms. Atleast a portion of the electrode, in some embodiments, may include arod-like body and a pointed or tapered tip, thereby resembling a needle.Because of this needle-like shape, and because the electrode 32 replacesthe needle used during conventional acupuncture therapy, the electrode32 may also be referred to herein as a “needle electrode”. However, analternate and preferred electrode form to replace a “needle electrode”is a smooth surface electrode, without any sharp or pointed edges.

For the embodiment shown in the top right portion of FIG. 18, and forthe IEAD 30, the electrode 32 forms an integral part of the housing 31of the IEAD 30, and is located on a “front” side of the IEAD housingapproximately in the center of the housing. As used here, “front” meansthe side of the housing that fronts or faces the tissue to bestimulated. Frequently, but not always, the front side is the side ofthe IEAD housing 31 farthest from the skin layer 12, or deepest in thebody tissue. Other embodiments may incorporate an electrode that is notcentered in the housing 31, and that is not even on the front side ofthe housing, but is rather on an edge of the housing 31. Alternatively,as shown in the bottom right of FIG. 18, the electrode 32 may be locatedat the distal end of a short lead 41, e.g., nominally 10-20 mm long, butin some instances it may be up to 50 mm long, implanted with a strainrelief loop to isolate movement of the case from the electrode. Theproximal end of the lead, which may also be referred to herein as a“pigtail lead”, is attached to the IEAD 30 along an edge of the IEADhousing 31 or at a suitable connection point located on a side of theIEAD 30. Alternate configurations for attaching the proximal end of thelead 41 to the IEAD housing 31 are illustrated in Appendix F.

When implanted, the IEAD 30 is positioned such that the electrode 32resides near, directly over, or otherwise faces the target tissuelocation, e.g., the desired acupoint or nerve, that is to be stimulated.For those embodiments where the electrode 32 forms an integral part ofthe housing 31 of the IEAD 30, there is thus no need for a long leadthat must be tunneled through body tissue or blood vessels in order toplace the electrode at the desired acupoint or nerve. Moreover, even forthose embodiments where a very short lead may be employed between theIEAD 30 and the electrode 32, the tunneling required, if any, is ordersof magnitude less than the present state of the art. In fact, with anelectrode lead of between 20 mm and 50 mm in length, it is probable thatno tunneling will be required. Further, because the electrode eitherforms an integral part of the IEAD housing 31, or is attached to theIEAD housing using a very short pigtail lead, the entire IEAD housing 31serves as an anchor to hold or secure the electrode 32 in its desiredlocation.

For the embodiment depicted in the top right of FIG. 18 and as mentionedabove, the electrode 32 is located in the center of the front side ofthe IEAD 30. As explained in more detail below, this positioning of theelectrode 32 is only exemplary, as various types of electrodes may beemployed, as well as various numbers of electrodes and relativepositioning. See, e.g., FIGS. 20 through 21C, and accompanying text,presented below. See also, Appendix A and Appendix B.

Still referring to FIG. 18, the EA System 10 also includes an externalcontrol unit, or ECD, 20. The role that the ECD 20 plays in theoperation of the EA system varies as a function of which embodiment ofthe EA System is being used. A USB port 211, located on one side of theECD, allows it to be connected to a PC or notebook computer or othersuitable processor for diagnostic, testing, or programming purposes.Other ports or connectors may also be used on the ECD 20, as needed bythe various embodiments employed. In its simplest form, however, the ECD20 may take the form of a handheld magnet, described in more detailbelow in conjunction with a specific example of the invention.

FIG. 19 is a Table that highlights the main embodiments of the EA System10, and provides a summary description of the functions performed by theExternal Controller 20 and IEAD 30 in each embodiment. It is importantto note that the list of embodiments identified in FIG. 19 is not acomplete list, but is only representative of four of the manyembodiments that could be employed. Thus, the embodiments highlighted inFIG. 19 include, but are not limited to:

Embodiment I

Embodiment I comprises a fully implantable EA System wherein the IEAD 30provides the desired stimulation as controlled by an internal program,or stimulation regime, programmed into its circuits. When thusconfigured, the External Controller 20 is used in Embodiment I only as aprogrammer to program the operating parameters of the IEAD 30. When theIEAD 30 is operating, all of its operating power is obtained from apower source carried within the IEAD 30.

Embodiment II

Embodiment II is essentially the same as Embodiment I except that theExternal Controller 20 is used, when needed, to both program the IEAD 30and to recharge or replenish a rechargeable and/or replenishable powersource carried within the IEAD 30.

Embodiment III

In Embodiment III, all or most all of the functions of the EA System areperformed within the External Controller 20 except for delivery of thedesired stimuli to the desired acupoint through the electrode 32. Hence,when the EA System operates using Embodiment III, the ExternalController 20 must always be present and RF-coupled ormagnetically-coupled to the IEAD 20. That is, in Embodiment III, theExternal Controller 20 generates the stimulation energy at the desiredtime, duration and intensity. Then, it sends, i.e., transmits, thisenergy through the skin 12 to the implantable electroacupuncturestimulator 30. Such transmission of energy through the skin is typicallydone through electromagnetic coupling, e.g., inductive coupling, muchlike a transformer couples energy from its primary coil to its secondarycoil. For coupling through the skin, the primary coil is located in theExternal Controller 20 and the secondary coil is located in the IEAD 30.The IEAD 30 receives this energy and simply passes it on to theelectrode 32 via interconnecting conductive traces or wires. EmbodimentIII is particularly useful for diagnostic and data-gathering purposes,but can also be used by a patient who does not mind occasionally wearingan external device positioned on his or her skin over the location wherethe IEAD is implanted whenever the EA System is operational.

Embodiment IV

In Embodiment IV, the EA system is a fully, self-contained, implantableIEAD except for the use of an external “passive” control element, suchas a magnet. The external control element is used to perform very basicfunctions associated with the IEAD, such as turning the IEAD OFF or ON,changing the intensity of stimulus pulses by a small amount, slightlymodifying the timing of stimulation sessions, resetting the parametersof the stimulation regimen back to default values, and the like.

A preferred stimulation regimen for use with the selected acupointsstimulates the selected target acupoint over several months or years,but at a very low duty cycle, e.g., applying a stimulation session thathas a duration of 30 to 60 minutes only once or twice a week. Forpurposes of the present invention, Applicant has determined that if astimulation session has a duration of T3 minutes, and if the timebetween stimulation sessions is T4 minutes, the duty cycle, or ratio ofT3/T4, should be no greater than 0.05.

One advantage of providing stimulation pulses using a low duty cycle, asdescribed above, is that the power source of the IEAD 30 is able topower operation of the IEAS over long periods of time. Through carefulpower management, detailed more fully below in conjunction with thedescription of a specific example, the IEAD 30 may operate for severalyears.

Turning next to FIGS. 20, 20A and 20B, a mechanical drawing of oneembodiment of the housing 31 of the implantable electroacupuncturestimulator 30 is illustrated, along with various types of electrodesthat may be used therewith. In a first embodiment, as seen in FIG. 20,the housing 31 of the IEAD 30 is preferably disc-shaped, having adiameter “d1” and width “w1”. The housing 31 is made from a suitablebody-tissue-compatible (biocompatible) metal, such as Titanium orstainless steel, having a thickness of 0.2 to 1.0 mm. An electrode 32resides at the center of the front side of the housing 31. The frontside of the housing 31 is the side facing out of the paper in FIG. 20,and is the side faces the target tissue to be stimulated. Most often,this is the side that is farthest away from the surface of the skin whenthe stimulator device is implanted in a patient. Thus, the front side isalso sometimes referred to as the “underneath” side of the device.

The electrode 32 is surrounded by a ceramic or glass section 34 thatelectrically insulates the electrode 32 from the rest of the housing 31.This ceramic or glass 34 is firmly bonded (brazed) to the metal of thehousing 31 to form an hermetic seal. Similarly, a proximal end 35 of theelectrode 34, best seen in the sectional views of FIG. 20A or 20B,passes through the ceramic or glass 34, also forming an hermetic seal.The resultant structure resembles a typical feed-through pin commonlyused in many implantable medical devices, and allows electricalconnection to occur between electrical circuitry housed within thehermetically-sealed housing and body tissue located outside of thehermetically-sealed housing.

In the embodiment of the housing 31 shown in FIGS. 20, 20A and 20B, theelectrode 32 is shown formed to have a narrow tip, much like a needle.Hence, the electrode 32 is sometimes referred to as a needle electrode.It is commonly taught that a needle electrode of this type generallyallows the electric fields associated with having a current flowing outof or into the needle tip to be more sharply focused, and thereby allowsthe resultant current flow through the body tissue to also be moresharply focused. This helps the electrical stimulation to be appliedmore precisely at the desired acupuncture point. Further, because mostacupoints tend to exhibit a lower resistance than do non-acupoints, theamount of power required to direct a stimulation current through theacupoint is lower, thereby helping to conserve power.

However, as will be explained in more detail below in conjunction withApplicant's specific example (Section II), Applicant's preferredelectrode shape is smooth, and symmetrical, which shape andconfiguration allow the resultant electric fields to deeply penetrateinto the desired target tissue.

As is known in the art, all electrical stimulation requires at least twoelectrodes, one for directing, or sourcing, the stimulating current intobody tissue, and one for receiving the current back into the electroniccircuitry. The electrode that receives the current back into theelectronic circuit is often referred to as a “return” or “ground”electrode. The metal housing 31 of the IEAD 30 may function as a returnelectrode during operation of the IEAD 30.

FIG. 20A is a sectional view, taken along the line A-A of FIG. 20, thatshows one embodiment of the IEAD housing wherein the needle electrode 32resides in a cavity 37 formed within the front side of the IEAD housing31.

FIG. 20B is a sectional view, taken along the line A-A of FIG. 20, andshows an alternative embodiment of the front side of the IEAD whereinthe needle or other electrode 32 forms a bump that protrudes out fromthe front surface of the IEAD a short distance.

FIG. 20C is a sectional view, taken along the line A-A of FIG. 20, andshows yet another alternative embodiment where a short lead 41, having alength L1, extends out from the housing 31. The electrode 32, which maybe formed in many shapes, is located at a distal end of the lead 41. Theshapes of the electrode, for example, may be a ball, cone or taperedcylindrical, ring, bullet shaped or full or half cuffed, with electrodeanchoring features. See, e.g., Appendix F, where various shapedelectrodes at the end of a short pigtail lead are illustrated. Thelength L1 of this short electrode is nominally 10-20 cm, but may extendas long as 50 mm. A proximal end of the lead 41 attaches to the housing31 of the IEAD 30 through a feed-through type structure made of metal 35and glass (or ceramic) 34, as is known in the art.

Next, with reference to FIGS. 21, 21A, 21B, and 21C, there is shown anembodiment of the IEAD 30 that shows the use of four needle electrodesintegrated within the housing 31 of an IEAD 30. The needle electrodes 32have a tip 33 that protrudes away from the surface of the housing 31 ashort distance. A base, or proximal, portion of the needle electrodes 32is embedded in surrounding glass or ceramic 34 so as to form an hermeticbond between the metal and ceramic. A proximal end 35 of the needleelectrode 32 extends into the housing 31 so that electrical contact maybe made therewith. The ceramic or glass 34 likewise forms a metallicbond with the edge of the housing 31, again forming an hermetic bond.Thus, the needle electrodes 32 and ceramic 34 and metal housing 31function much the same as a feed-through pin in a conventionalimplantable medical device housing, as is known in the art. Suchfeed-through pin allows an electrical connection to be establishedbetween electrical circuitry housed within the hermetically-sealedhousing 31 and body tissue on the outside of the hermetically sealedhousing 31.

Having four needle electrodes arranged in a pattern as shown in FIG. 21allows a wide variation of electric fields to be created emanating fromthe tip 33 of each needle electrode 32 based on the magnitude of thecurrent or voltage applied to each electrode. That is, by controllingthe magnitude of the current or voltage at each tip 32 of the fourelectrodes, the resulting electric field can be steered to a desiredstimulation point, i.e., to the desired electroacupuncture (EA) point ornerve.

FIG. 21C is a also a sectional view, taken along the line B-B of FIG.21, that shows yet another embodiment of the EA device where theelectrodes comprise small conductive pads 47 at or near the distal endof a flex circuit cable 45 that extends out from the underneath surfaceof the IEAD a very short distance. To facilitate a view of the distalend of the flex circuit cable 45, the cable is shown twisted 90 degreesas it leaves the underneath surface of the IEAD 30. When implanted, theflex circuit cable 45 may or may not be twisted or have a strain reliefloop, depending upon the relative positions of the IEAD 30 and thetarget acupoint to be stimulated. As can be seen in FIG. 21C, at thedistal end of the flex circuit cable 45 the four electrodes 32 arearranged in a square pattern array. Other arrangements of the electrodes32 may also be employed, a linear array, a “T” array, and the like. Manyother alternate electrode configurations are illustrated, e.g., inAppendix A and Appendix B.

While only one or four electrodes 32 is/are shown as being part of thehousing 31 or at the end of a short lead or cable in FIGS. 20 and 21,respectively, these numbers of electrodes are only exemplary. Any numberof electrodes, e.g., from one to eight electrodes, that conveniently fiton the underneath or front side or edges of an IEAD housing 31, or on apaddle array (or other type of array) at the distal end of a short lead,may be used. The goal is to get at least one electrode (whether anactual electrode or a virtual electrode—created by combining theelectric fields emanating from the tips of two or more physicalelectrodes) as close as possible to the target EA point, or acupoint.When this is done, the EA stimulation should be more effective.

Next, with reference to FIGS. 22A through 22E, various alternate shapesof the housing 31 of the IEAD 30 that may be used with an EA System 10are illustrated. The view provided in these figures is a side sectionalview, with at least one electrode 32 also being shown in a sidesectional view. In FIGS. 22A through 22D, the electrode 32 iselectrically insulated from the housing 31 by a glass or ceramicinsulator 34. A portion of the electrode 32 passes through the insulator34 so that a proximal end 35 of the electrode 32 is available inside ofthe housing 31 for electrical contact with electronic circuitry that ishoused within the housing 31.

In FIG. 22A, the housing 31 is egg shaped (or oval shaped). A bump orneedle type electrode 32 protrudes a small distance out from the surfaceof the housing 31. While FIG. 22A shows this electrode located more orless in the middle of the surface of the egg-shaped housing, thispositioning is only exemplary. The electrode may be located anywhere onthe surface of the housing, including at the ends or tips of the housing(those locations having the smallest radius of curvature).

In FIG. 22B, the housing 31 of the IEAD 30 is spherical. Again, a bumpor needle-type electrode 32 protrudes out a small distance from thesurface of the housing 31 at a desired location on the surface of thespherical housing. The spherical housing is typically made by firstmaking two semi-spherical housings, or shells, and then bonding the twosemi-spherical housings together along a seam at the base of eachsemi-spherical shell. The electrode 32 may be located at some pointalong or near this seam.

In FIG. 22C, the housing 31 is semi-spherical, or dome shaped. A bump orneedle electrode 32 protrudes out from the housing at a desiredlocation, typically near an edge of the base of the semi-spherical ordome-shaped housing 31.

In FIG. 22D, the housing is rectangular in shape and has rounded edgesand corners. A bump or needle electrode 32 protrudes out from thehousing at a desired location on the underneath side of the housing, oralong an edge of the housing. As shown in FIG. 22D, one location forpositioning the electrode 32 is on the underneath side near the edge ofthe housing.

In FIG. 22E, the housing 31 is key shaped, having a base portion 51 andan arm portion 53. FIG. 22E includes a perspective view “A” and a sidesectional view “B” of the key-shaped housing 31. As shown, the electrode32 may be positioned near the distal end of the arm portion 53 of thehousing 31. The width of the arm portion 53 may be tapered, and all thecorners of the housing 31 are rounded or slanted so as to avoid anysharp corners. The key-shaped housing shown in FIG. 22E, or variationsthereof, is provided so as to facilitate implantation of the IEAD 30through a small incision, starting by inserting the narrow tip of thearm portion 53, and then sliding the housing under the skin as requiredso that the electrode 32 ends up being positioned over, adjacent or onthe desired acupoint.

In lieu of the bump or needle-type electrodes 32 illustrated in FIGS.22A through 22C, a smooth, flat or other non-protruding electrode 32 mayalso be used.

It is to be noted that while the various housing shapes depicted inFIGS. 22A through 22E have a bump or needle-type electrode (and whichcould also be a flat or smooth electrode as noted in the previousparagraph) that form an integral part of the IEAD housing 31, electrodesat the distal end of a short lead connected to the IEAS housing may alsobe employed with any of these housing shapes.

It is also to be emphasized that other housing shapes could be employedfor the IEAD 30 other than those described. For example, reference ismade to the alternate case shapes shown in Appendix E. The inventiondescribed and claimed herein is not directed so much to a particularshape of the housing 31 of the IEAD 30, but rather to the fact that theIEAD 30 need not provide EA stimulation on a continuous basis, but mayoperate using a very low duty cycle, and therefore the power sourcecarried in the IEAD need not be very large, which in turn allows theIEAS housing 31 to be very small. The resulting small IEAD 30 may thenadvantageously be implanted directly at or near the desired acupoint,without the need for tunneling a lead and an electrode(s) over a longdistance, as is required using prior art implantable electroacupuncturedevices. Instead, the small IEAD 30 used with the present inventionapplies its low duty cycle, non-continuous EA stimulation regime at thedesired acupoint without the use of long leads and extensive tunneling,which stimulation regime applies low intensity, low frequency and lowduty cycle stimulation at the designated acupoint over a period ofseveral years in order to improve dyslipidemia or obesity (or treatwhatever other condition, illness or deficiency is being treated).

Turning next to FIG. 23, an electrical functional block diagram of theelectrical circuitry and electrical components housed within the IEAD 30and the External Controller 20 is depicted. The functional circuitryshown to the right of FIG. 4 is what is typically housed within the IEAD30. The functional circuitry shown to the left of FIG. 4 is what istypically housed within the External Control Device 20, also referred toas an External Controller 20. How much circuitry is housed within theIEAD 30 and how much is housed within the External Controller 20 is afunction of which embodiment of the EA System 10 is being used.

It is to be noted and emphasized that the circuitry shown in FIG. 23,and in the other figures which show such circuitry, is intended to befunctional in nature. In practice, a person of skill in the electrical,bioelectrical and electronic arts can readily fashion actual circuitsthat will perform the intended functions. Such circuitry may berealized, e.g., using discrete components, application specificintegrated circuits (ASIC), microprocessor chips, gate arrays, or thelike.

As seen in FIG. 23, the components used and electrical functionsperformed within the IEAD 30 include, e.g., a power source 38, an outputstage 40, an antenna coil 42, a receiver/demodulator circuit 44, astimulation control circuit 46, and a reed switch 48. The componentsused and electrical functions performed with the External Controller 20include, e.g., a power source 22, a transmission coil 24, a centralprocessing unit (CPU) 26, a memory circuit 25, a modulator circuit 28and an oscillator circuit 27. The External Controller 20 also typicallyemploys some type of display device 210 to display to a user the statusor state of the External Controller 20. Further, an interface element212 may be provided that allows, e.g., a means for manual interface withthe Controller 210 to allow a user to program parameters, performdiagnostic tests, and the like. Typically, the user interface 212 mayinclude keys, buttons, switches or other means for allowing the user tomake and select operating parameters associated with use of the EASystem 10. Additionally, a USB port 211 is provided so that the ExternalController 20 may interface with another computer, e.g., a laptop ornotebook computer. Also, a charging port 213 (which may also be in theform of a USB port) allows the power source 22 within the ExternalController 20 to be recharged or replenished, as needed.

In operation, the Stimulation Control Circuit 46 within the IEAD 30 hasoperating parameters stored therein that, in combination withappropriate logic and processing circuits, cause stimulation pulses tobe generated by the Output Stage 40 that are applied to at least one ofthe electrodes 32, in accordance with a programmed or selectedstimulation regime. The operating parameters associated with suchstimulation regime include, e.g., stimulation pulse amplitude, width,and frequency. Additionally, stimulation parameters may be programmed orselected that define the duration of a stimulation session (e.g. 15, 30,45 or 60 minutes), the frequency of the stimulation sessions (e.g.,daily, twice a day, three times a day, once every other day, etc.) andthe number of continuous weeks a stimulation session is applied,followed by the number of continuous weeks a stimulation session is notapplied.

The Power Source 38 within the IEAD 30 may comprise a primary battery, arechargeable battery, a supercapacitor, or combinations or equivalentsthereof. For example, one embodiment of the power source 38, asdiscussed below in connection with FIG. 26, may comprise a combinationof a rechargeable battery and a supercapacitor.

When describing the power source 38, the terms “recharge”, “replenish”,“refill”, “reenergize”, and similar terms (or variations thereof), maybe used interchangeably to mean to put energy into a depleted reservoirof energy. Thus, e.g., a rechargeable battery when it is run down isrecharged. A supercapacitor designed to hold a large volume ofelectrical charge has its store of electrical charge replenished. Apower source that comprises a combination of a rechargeable battery anda supercapacitor, or similar devices, is reenergized. In other words, asthe stored energy within an EA device is consumed, or depleted, thestore of energy within the EA device, in some embodiments, may bereplenished, or the energy reservoir within the EA device is refilled.In other embodiments, the EA device may simply and easily be replaced.

The antenna coil 42 within the IEAD 30, when used (i.e., when the IEAD30 is coupled to the External Controller 20), receives an ac powersignal (or carrier signal) from the External Controller 20 that may bemodulated with control data. The modulated power signal is received anddemodulated by the receiver/demodulator circuit 44. (Thereceiver/demodulator circuit 44 in combination with the antenna coil 42may collectively be referred to as a receiver, or “RCVR”.) Typically thereceiver/demodulator circuit 44 includes simple diode rectification andenvelope detection, as is known in the art. The control data, obtainedby demodulating the incoming modulated power signal, is sent to theStimulation Control circuit 46 where it is used to define the operatingparameters and generate the control signals needed to allow the OutputStage 40 to generate the desired stimulation pulses.

It should be noted that the use of coils 24 and 42 to couple theexternal controller 20 to the IEAD 30 through, e.g., inductive or RFcoupling, of a carrier signal is not the only way the externalcontroller and IEAS may be coupled together, when coupling is needed(e.g., during programming and/or recharging). Optical or magneticcoupling, for example, may also be employed.

The control data, when present, may be formatted in any suitable mannerknown in the art. Typically, the data is formatted in one or morecontrol words, where each control word includes a prescribed number ofbits of information, e.g., 4 bits, 8 bits, or 16 bits. Some of thesebits comprise start bits, other bits comprise error correction bits,other bits comprise data bits, and still other bits comprise stop bits.

Power contained within the modulated power signal is used to recharge orreplenish the Power Source 38 within the IEAD 30. A return electrode 39is connected to a ground (GRD), or reference, potential within the IEAD30. This reference potential may also be connected to the housing 31(which housing is sometimes referred to herein as the “case”) of theIEAD 30.

A reed switch 48 may be employed within the IEAD 30 in some embodimentsto provide a means for the patient, or other medical personnel, to use amagnet placed on the surface of the skin 12 of the patient above thearea where the IEAD 30 is implanted in order to signal the IEAS thatcertain functions are to be enabled or disabled. For example, applyingthe magnet twice within a 2 second window of time could be used as aswitch to manually turn the IEAD 30 ON or OFF.

The Stimulation Control Circuit 46 used within the IEAD 30 contains theappropriate data processing circuitry to enable the Control Circuit 46to generate the desired stimulation pulses. More particularly, theControl Circuit 46 generates the control signals needed that will, whenapplied to the Output Stage circuit 40, direct the Output Stage circuit40 to generate the low intensity, low frequency and low duty cyclestimulation pulses used by the IEAD 30 as it follows the selectedstimulation regime. In one embodiment, the Control circuit 46 maycomprise a simple state machine realized using logic gates formed in anASIC. In other embodiments, it may comprise a more sophisticatedprocessing circuit realized, e.g., using a microprocessor circuit chip.

In the External Controller 20, the Power Source 22 provides operatingpower for operation of the External Controller 20. This operating poweralso includes the power that is transferred to the power source 38 ofthe IEAD 30 whenever the implanted power source 38 needs to bereplenished or recharged. Because the External Controller 20 is anexternal device, the power source 22 may simply comprise a replaceablebattery. Alternatively, it can comprise a rechargeable battery.

The External Controller 20 generates a power (or carrier) signal that iscoupled to the IEAD 30 when needed. This power signal is typically an RFpower signal (an AC signal having a high frequency, such as 40-80 MHz).An oscillator 27 is provided within the External Controller 20 toprovide a basic clock signal for operation of the circuits within theExternal Controller 20, as well as to provide, either directly or afterdividing down the frequency, the AC signal for the power or carriersignal.

The power signal is modulated by data in the modulator circuit 28. Anysuitable modulation scheme may be used, e.g., amplitude modulation,frequency modulation, or other modulation schemes known in the art. Themodulated power signal is then applied to the transmitting antenna orcoil 24. The external coil 24 couples the power-modulated signal to theimplanted coil 42, where the power portion of the signal is used toreplenish or recharge the implanted power source 38 and the data portionof the signal is used by the Stimulation Control circuit 46 to definethe control parameters that define the stimulation regime.

The memory circuit 25 within the External Controller 20 stores neededparameter data and other program data associated with the availablestimulation regimes that may be selected by the user. In someembodiments, only a limited number of stimulation regimes are madeavailable for the patient to use. Other embodiments may allow the useror other medical personnel to define one or more stimulation regimesthat is/are tailored to a specific patient.

Turning next to FIG. 24, there is shown a functional diagram of anOutput Stage 40-1 that may be used within the IEAD 30 for Embodiment III(See FIG. 18A and accompanying text for a description of EmbodimentIII). The Output Stage 40-1 is basically a pass-through circuit, whereinthe entire IEAD 30 comprises nothing more than an electrode 32 connectedto a coil 42-1, all of which is carried within an IEAD housing 31. Insome embodiments, some simple passive filtering circuitry 424 may alsobe used to filter and shape the signal being passed from the coil 42-1to the electrode(s) 32. Such a simple IEAD housing 31 allows themechanical functions of the IEAD 30 (size, implant location,effectiveness of EA stimulation, etc.) to be implanted and fully testedwithout initially incurring the additional expenses associated with afully functional IEAD 30.

As indicated in the previous paragraph, the function of the simplifiedIEAD 30 shown in FIG. 24 is to pass the signal received at the antennacoil 42-1 on to the electrode(s) 32. More particularly, a signal burst240, when applied to a coil 24-1 in the External Controller 20, iselectromagnetically (e.g., inductively) coupled to the coil 42-1 withinthe Output Stage 40-1 of the IEAD 30, where it appears as signal burst420. The signal burst 420 received by the implanted coil 42-1 may have adifferent intensity than does the signal burst 240 as a function of thecoupling efficiency between the two coils 24-1 and 42-1, the number ofturns in each coil, and the impedance matching that occurs between thecircuits of the External Controller 20 and the combined load attached tothe Output Circuit 40-1, which combined load includes the implanted coil42-1, the electrode 32 and the body tissue in contact with the electrode32. This different intensity may still be sufficiently controlled by theExternal Controller so that the energy contained within the signal burst420, defined in large part by the envelope of the signal burst 240, issufficient to stimulate the tissue at the desired electroacupuncturesite, or acupoint, thereby producing, over time, the desired therapeuticeffect.

In some embodiments, passive filtering circuitry 424 may also be usedwithin the Output Stage 401 to reconfigure or reshape the energy of thesignal burst 240 into a suitable stimulation pulse 422. This stimulationpulse 422 is then applied to the electrode 32 through a couplingcapacitor C.

As mentioned previously, the Output Stage circuit 40-1 shown in FIG. 24is ideally suited for diagnostic and data gathering purposes.Nonetheless, such embodiment can also be effectively used by a patientwho does not object to wearing an External Controller 20 on his or herwrist or leg when the stimulation sessions associated with use of the EASystem 10 are employed.

FIG. 25A functionally shows a representative Output Stage 40-2 that maybe used when voltage stimulation is applied through the electrode(s) 32to the desired acupoint. As seen in FIG. 25A, a positive voltage source,+V, and a negative voltage source, —V, are selectively and sequentiallyapplied to an electrode 32, through switches SW1 and SW2. A couplingcapacitor is preferably employed to prevent dc current from flowingthrough the electrode 32. If more than one electrode 32 is employed, asingle pair of voltage sources may be selectively connected to eachelectrode using a suitable multiplexer circuit (not shown in FIG. 6A),as is known in the art.

FIG. 25B functionally shows a representative Output Stage circuit 40-3that may be used when current stimulation is applied through theelectrode(s) 32 to the desired acupoint. As seen in FIG. 25B, a positivecurrent source, +I, and a negative current source, —I, are selectivelyapplied to an electrode 32. In some embodiments, the current sourcescomprise independent programmable current sources that can readily beprogrammed to source, or sink, a precise current magnitude, as is knownin the art. Advantageously, use of independent programmable currentsources in this fashion allows, when multiple electrodes 32 are used,precise sharing of the currents in order to steer the electric fieldsemanating from the electrodes in a desired manner. For example, if threeelectrodes 32 were employed, a first of which sources 200 microamps (ma)of current, and thus functions as an anode, and a second and third ofwhich each sink 100 ma, each thus functioning as cathodes, the resultingelectric fields would make it appear that a virtual electrode existed atsome point along a mid-point line between the second and thirdelectrodes. Such steering of a virtual electrode would thus allow theeffectiveness of the EA stimulation to be adjusted or tuned, whicheffectiveness is largely a function of the proximity between theacupoint site and the electrode. Advantageously, this adjustment, ortuning, can occur even after the IEAD 30 is implanted with a fixedphysical location of the electrodes relative to the desired acupointsite.

FIG. 26 illustrates a power source configuration 38-1 that may be usedin some embodiments within the IEAD 30 for the implanted power source38. The power source configuration 38-1 shown in FIG. 26 employs both arechargeable battery 380 and a supercapacitor 382, connected inparallel. The rechargeable battery 380 is charged in conventional mannerusing power received from the recharge circuits. For most embodiments,this would be the power received through implanted coil 42 and theReceiver circuit 44 (see FIG. 23). The power stored in the battery 380may thereafter be used to trickle charge the supercapacitor at timeswhen the IEAD 30 is not stimulating body tissue. Then, when there is ademand for a pulse of stimulation current, the energy required for suchpulse may be pulled from the super capacitor in a relatively rapiddischarge mode of operation. Diodes D1 and D2 are used to isolate thesupercapitor 382 from the battery 380 when the supercapacitor isundergoing a rapid discharge.

Next, with respect to FIGS. 27 and 28, timing diagrams are shown toillustrate a typical stimulation regime that may be employed by the EASystem 10. First, as seen in FIG. 27, the electroacupuncture (EA)stimulation pulses preferably comprise a series of biphasic stimulationpulses of equal and opposite polarity for a defined time period T1seconds. Thus, as seen at the left edge of FIG. 27, a biphasicstimulation pulse 250 comprises a pulse having a positive phase ofamplitude+P1 followed by a negative phase having an amplitude of −P1.(Alternatively, the biphasic stimulation pulse could comprise a pulsehaving a negative phase of amplitude −P1 followed by a positive phase ofamplitude+P1.) Each phase has a duration of T1/2 seconds, or the entirebiphasic pulse has a total duration of T1/2+T1/2=T1 seconds. (Thisassumes the positive phase duration is equal to the negative phaseduration, which is usually the case for a biphasic stimulation pulse.)The rate at which the biphasic pulses occur is defined by the timeperiod T2 seconds. FIG. 27 makes it appear that T2 is approximatelytwice as long as T1. However, this is not necessarily the case. In manystimulation regimes, T2 may be many times longer than T1. For example,the time T1 may be only 20 milliseconds (ms), with each phase being 10ms, but the time T2 may be one second, or 1000 ms, or two seconds (2000ms). The time periods T1 (pulse width) and T2 (pulse rate) are thusimportant parameters that define a preferred stimulation regime. Theratio of T1/T2 defines the duty cycle of the stimulation pulses when thestimulation pulses are being applied during a stimulation session.

Still referring to FIG. 27, the next parameter shown is the stimulationsession period, or T3. This is the time over which stimulation pulses ofwidth T1 are applied at a rate T2. The session length T3, for example,may be 15, 30, 45, 60, or 70 minutes, or any other suitable value asselected by medical personnel for delivery to a specific patient.

The stimulation session, in turn, is also applied at a set rate, asdetermined by the time period T4. Typical times for T4 include 24 or 48hours, or longer, such as one week or two weeks. Thus, for example, ifT4 is 24 hrs. T3 is 30 minutes, T2 is 1 second, and T1 is 20 ms, thenbiphasic stimulation pulses having a width of 20 ms are applied onceeach second for a session time of 30 minutes. The session, in turn, isapplied once every 24 hours, or once each day.

It should be noted that bi-phasic stimulation pulses as shown in FIG. 27are not the only type of stimulation pulses that may be used. In SectionII, below, another type of stimulation pulse (a negative-going pulse) isused with the specific example described there. A negative-going pulseis shown in FIG. 15A.

Next, as seen in FIG. 28, several variations of possible stimulationpatterns are illustrated. In the top line of FIG. 28, a fixed ratestimulation sequence is illustrated where a stimulation session, havinga duration of T3 seconds, is applied at a rate defined by time periodT4. If T3 is 30 minutes, and T4 is 24 hours, then the fixed stimulationrate is one stimulation session lasting 30 minutes applied once eachday.

The second line of FIG. 28 shows a stimulation pattern that uses a fixedstimulation rate and a fixed replenishing rate, which rates are thesame, occurring every T4 seconds. A replenishing signal is a signal fromwhich energy is extracted for charging or replenishing the implantedpower source 38. Frequently, the replenishing signal may itself bemodulated with data, so that whenever replenishing occurs, control datamay also be transmitted. This control data can be new data, as when astimulation regime is to be followed, or it can just be the same data asused previously, and it is used just to refresh or re-store the existingcontrol data.

A replenishing signal is illustrated in FIG. 28 as pulses 260, which aredrawn having a higher amplitude than the stimulation session pulses, andwhich have a duration of T6 seconds. It is noted that the time scale inFIG. 28 is not drawn to scale. Thus, whereas as illustrated in FIG. 28the stimulation session time T3 appears to be twice as long as thereplenishment time T6, such is not necessarily the case.

The third line in FIG. 28 shows an example of a replenishment signalbeing generated every T5 hrs, and a stimulation session occurring everyT4 hours. As shown in FIG. 28, T4 is significantly less than T5. Forexample, T5 may be 168 hours (1 week), whereas T4 may be 24 hours, oronce a day.

The last line in FIG. 28 illustrates a manual selection of theoccurrence of a stimulation session and of a replenishment session.Hence, no rate is associated with either of these events. They simplyoccur whenever they are selected to occur. Selection can be made throughuse of the External Controller 20, or in the case of a stimulationsession (where no external recharging power is needed), through use ofthe reed switch 48). One type of manually-triggered stimulation isillustrated below in the flow diagram of FIG. 30.

Turning next to FIG. 29, a flow chart is shown that illustrates a method500 for automatically applying continuous stimulation sessions inaccordance with a prescribed stimulation regimen. Such method 500applies stimulation sessions having a fixed duration of T3 minutes everyT4 minutes. As seen in FIG. 29, such method is carried out by starting astimulation session (block 502). During the stimulation session, theelapsed time is monitored and a determination is made as to whether thetime period T3 has elapsed (block 504). If not (NO branch of block 504),the time monitoring continues. Once the time period T3 has elapsed (YESbranch of block 504), the stimulation session is stopped (block 506).However, even with the stimulation session stopped, time continues to bemonitored (block 508). When the time T4 has elapsed (YES branch of block508) then a determination is made as to whether a Shut Down mode shouldbe entered (block 510). If so (YES branch of block 510), then theapplication of stimulation sessions is stopped (block 512). If not (NObranch of block 510), then a new stimulation session of T3 minutesbegins (block 502), and the process continues. The timing waveformdiagram corresponding to the flow diagram of FIG. 29 is the top waveformin FIG. 28.

A variation of the method 500 depicted in FIG. 29 is to alternate thetime periods of the stimulation session duration, T3, between twodifferent values. That is, T3 is set to toggle between a first value T3₁ for the stimulation session duration and a second value T3 ₂ for thestimulation session, with the value T3 ₁ being used every otherstimulation session. Thus, a time line of the method of treatingdyslipidemia or obesity follows a sequence T3 ₁—T4—T3 ₂—T4—T3 ₁—T4—T3₂—T4 — . . . and so on, where T4 is the time period between stimulationsessions.

If such a method is followed of toggling between two values of T3,representative values for T3 ₁ and T3 ₂ could be to set T3 ₁ to a valuethat ranges between 10 minutes and 40 minutes, and to set T3 ₂ to avalue that ranges between 30 minutes and 60 minutes.

Similarly, a further variation of this method of treating dyslipidemiaor obesity would be to toggle the value of T4, the time betweenstimulation sessions, between two values. That is, in accordance withthis method, the time T4 would be set to toggle between a first value T4₁ and a second value T4 ₂, with the value T4 ₁ being used after everyother stimulation session. Thus, a time line of this method of treatingdyslipidemia would follow a sequence T3—T4 ₁—T3—T4 ₂—T3—T4 ₁—T3—T4₂—T3—T4 ₁ . . . and so on, where T3 is the duration of the stimulationsessions.

If such method is followed, representative values for T4 ₁ and T4 ₂could be to set T4 ₁ to a value that ranges between 1440 minutes [1 day]and 10,080 minutes [1 week], and to set T4 ₂ to a value that rangesbetween 2,880 minutes [2 days] and 20,160 minutes [2 weeks].

Additional variations of these methods of toggling between differentvalues of T3 and T4 are also possible. For example, multiple values ofT3—T3 ₁, T3 ₂, T3 ₃, T3 ₄, T3 ₅ . . . T3 _(n)—could be set, and then thevalues could be used in sequence, or randomly during successivestimulation sequences. Multiple values of T4 could also be employed, andthe various values of T3 and T4 could be combined together in thesequences followed.

Further, as has already been mentioned, the frequency of the stimuliapplied during a stimulation session can also vary. For example, duringa stimulation session the frequency may vary from 5 Hz to 15 Hz withseveral different frequencies applied during any session. If T3 is 45minutes, then the stimulation frequency of the stimulus pulses could be,e.g., 10 minutes at 12 Hz, then 10 minutes at 10 Hz, then 10 minutes at8 Hz, then 15 minutes at 6 Hz, for a total duration of 45 minutes. Theamplitude of the stimulus pulses at all frequencies could be constant orvaried, e.g., between 2 mA and 10 mA. The rate of occurrence forstimulus sessions, T4, could be set to be as infrequently as once everytwo weeks or as frequently as twice daily.

If such methods are used to adjust the values of T3 and T4, care must beexercised to not exceed the maximum duty cycle associated with thepreferred stimulation regimens. That is, the invention requires that theratio of T3/T4 be no greater than 0.05. Thus, if either, or both, T3 andT4 are varied, limits should be placed on the ranges the parameters canassume in order to preserve the desired duty cycle. For example, therange of values within which T3 may be selected is typically between 10minutes and 70 minutes. The ranges of values within which T4 may beselected is normally between about 24 hours and 2 weeks. However, as thevalue of T4 decreases, and the value of T3 increases, a point is reachedwhere the maximum duty cycle could be exceeded. Thus, to prevent themaximum duty cycle from exceeding 0.05, the range of values for T3 andT4 may be specified by setting the time T3, the duration of thestimulation sessions, to be at least 10 minutes but no longer than amaximum value, T3(max). The value of T3(max) is adjusted, as needed, tomaintain the duty cycle, the ratio of T3/T4, at a value no greater than0.05. Thus, T3(max) is equal to 72 minutes if T4, the time periodbetween stimulation sessions is between 1,440 minutes [24 hours] and20,160 minutes [14 days]. However, T3(max) should be set to a value setby the equation T3(max)=0.05*T4 when T4 is between 720 minutes [½ day]and 1,440 minutes [20 hours].

Next, with reference to FIG. 30, there is depicted a flow chart for amethod 520 for manually triggering the application of stimulationsessions. When manual stimulation sessions are triggered, some basicparameters must still be observed. That is, there must be a minimumduration of a stimulation session T3(min), as well as a maximum durationof a stimulation session T3(max). Similarly, there needs to be a minimumtime period T4(min) that separates one stimulation session from another,and a maximum time period T4(max) allowed between stimulation sessionsbefore the next stimulation session is automatically started.Representative values for these parameters are, for example, T3(min)=10minutes, T3(max)=60 minutes, T4(min)=12 hours, and T4(max)=2 weeks.

With the basic operating parameters described above defined, the method520 shown in FIG. 29 proceeds by first determining whether a manualstart command (or trigger signal) has been received (block 522). If not(NO branch of block 522), then a determination is made as to whether thetime T4(max) has elapsed. If it has (YES branch of block 524), then astimulation session is started (block 526). If T4(max) has not elapsed(NO branch of block 524), then the IEAD 30 just keeps waiting for amanual trigger signal to occur (block 522).

If a manual trigger signal is received (YES branch of block 22), then adetermination is made as to whether T4(min) has elapsed (block 523).Only if T4(min) has elapsed (Yes branch of block 523) is a stimulationsession started (block 526). Thus, two consecutive stimulation sessionscannot occur unless at least the time T4(min) has elapsed since the laststimulation session.

During a stimulation session, the circuitry carrying out method 520 alsomonitors whether a manual stop signal has been received (block 528). Ifso (YES branch of block 528), then a determination is made as to whetherthe time T3(min) has elapsed. If not (NO branch of block 529), then thesession continues because the minimum session time has not elapsed. IfT3(min) has elapsed (YES branch of block 529), then the session isstopped (block 532). If a manual stop signal is not received (NO branchof block 528), and if T3(max) has not yet elapsed (NO branch of block530), then nothing happens (i.e., the session continues) until T3(max)has elapsed (YES branch of block 530), at which time the stimulationsession is terminated (block 532).

Still with reference to FIG. 30, once the session is stopped (block532), a determination is made whether the EA stimulation should shutdown (block 534). If so (YES branch of block 534) the stimulationterminates (block 536). If not, then the circuitry goes into a waitingmode where it monitors whether a manual start command is received, orthe time T4(max) elapses, whichever occurs first (blocks 522, 524), andthe next stimulation session is started (block 526). And, the processcontinues.

Thus, it is seen that the method 520 shown in FIG. 30 allows astimulation session to be manually started at any time a manual startcommand is received, providing that at least the time T4(min) haselapsed since the last session. Similarly, the method allows astimulation session to be manually stopped at any time during thestimulation session, providing that at least the time T3(min) haselapsed since the session started. Absent the occurrence of receiving amanual start command, the next session starts automatically afterT4(max) elapses. Similarly, during a stimulation session, absent a stopcommand, the session will stop automatically after the time T3(max) haselapsed.

Next, with reference to FIG. 31, a flow chart is shown that depicts onemethod 600 of using an EA System 10 of the type described herein, orequivalents thereof, to treat dyslipidemia. It is emphasized that themethod shown in FIG. 31 is just one of many methods that may be used,and includes steps or actions taken that may not always be needed nordesired. (Note that each step in the flow chart shown in FIG. 31 isrepresented by a rectangular (or other shaped) block having a referencenumber assigned to it. Once the action or other activity indicated in astep, or block, of the method is completed, then the method flows to thenext step, or block, in the flow chart. Decision steps are representedby a diamond (4-sided) or hexagonal (6-sided) shape, also having areference number assigned to it.) For example, the method shown in FIG.31 includes three decision steps or blocks, 612, 616 and 620, where,depending on the question being asked, one of two paths or branches mustbe followed. In a simplified version or embodiment of the method,however, these three decision blocks may be eliminated. In suchsimplified method, the method reduces to following the steps shown inblocks 602, 604, 606, 608, 610, 614, 620 and 622, which blocks aredescribed below.

For the method that uses the three decision blocks, as seen in FIG. 31,the method outlined in the flow diagram of FIG. 31 assumes that thecondition, illness or other physiological deficiency (hereafter“Condition”) being treated by the EA system 10 has been identified.Then, the method begins at block 602, which requires identifying thelocation of the appropriate acupoint(s) for treating the Conditionthrough the application of appropriate EA Modulation. Recall that, asused herein, “EA modulation” is the application of electricalstimulation pulses, at low intensities, frequencies and duty cycles, toat least one of the acupuncture points that has been identified asaffecting a particular illness, deficiency or condition. For treatingobesity or dyslipidemia, at least one of acupoints ST36, SP4, ST37,ST40, SP6, SP9, KI6, LRB, or certain underlying nerves, the peroneal andsaphenous nerves are identified. Other possible acupoints also exist, asdescribed previously. So, for purposes of completing the step describedat block 602, one of the possible acupoints that could be used isselected as the target acupoint.

Once the location of the target acupoint to be modulated has beenidentified, the next step (block 604) is to implant the IEAS 30 so thatits electrodes are firmly anchored and located so as to be near or onthe target acupoint. Then, after waiting a sufficient time for healingto occur associated with the implant surgery (block 606), which isusually just a week or two, the next step is to program the IEAD 30 withthe parameters of the selected stimulation regime that is to be followedby the IEAD 30 as it applies EA modulation to the target acupoint (block608). The parameters that define the selected stimulation regime includethe time periods T1, T2, T3, T4, T5 and T6 (described in connection withthe description of FIGS. 27 and 28), the intensity P1 of the stimulationpulses (also described previously in connection with FIG. 27), and thenumber of weeks, k, that EA modulation is to be applied beforemonitoring the Condition to see if improvement has occurred, as well asthe number of weeks, j, that EA modulation should be turned off beforerestarting the same or a new EA Modulation regime.

Once implanted and programmed, EA Modulation begins and continues for aperiod of k weeks (block 610). After k weeks, the patient's Condition,in this case dyslipidemia, is checked to see if it has improved(decision block 612). If YES, the EA Modulation is turned OFF for awaiting period of j weeks (block 614). After waiting j weeks, whilekeeping the EA Modulation deactivated, the Condition is again checked(decision block 616) to see if the condition has returned to itsprevious high blood pressure state, or to see if the improvement madehas lessened or deteriorated (decision block 616). If NOT, that is, ifthe Condition still remains at acceptable levels, then a decision may bemade by medical personnel in consultation with the patient as to whetherthe EA Modulation regime should be repeated in order to further help thepatient's body maintain the Condition at desired levels (decision block620).

If a decision is made to repeat the EA Modulation (YES branch ofdecision block 620), then the EA Modulation parameters are adjusted asneeded (block 622) and the EA Modulation begins again at the targetacupoint, following the programmed stimulation regime (block 610).

If a decision is made NOT to repeat the EA Modulation (NO branch ofdecision block 620), then that means the treatment for the Condition isover and the process stops (block 624). In such instance, the patientmay elect to have the IEAD 30 removed surgically, which is a very simpleprocedure.

Backtracking for a moment to decision block 612, where a decision wasmade as to whether the Condition had improved after the EA Modulationhad been applied for a period of k weeks, if the determination made isthat the Condition had not improved (NO branch of decision block 612),then again, medical personnel in consultation with the patient may makea decision as to whether the EA Modulation regime should be repeatedagain (block 620).

Further backtracking to decision block 616, where a decision was made asto whether, after the j weeks of applying no additional EA Modulation,the Condition had returned to its previous high blood pressure state, orthe improvement had lessened (YES branch of decision block 616), thenagain medical personnel in consultation with the patient may make adecision as to whether the EA Modulation regime should be repeated again(block 620).

In a simplified version of the method depicted in FIG. 31, only thesteps identified at blocks 602, 604, 606, 608, 610, 614, 620 and 622 arefollowed. This method thus reduces to identifying the target acupoint(block 602), implanting the IEAS at the target acupoint (block 604),waiting for the surgery to heal (block 606), programming EA simulationparameters into the IEAS (block 608) (which programming could actuallybe done before implanting the IEAS, if desired), applying EA modulationto the target acupoint for k weeks (block 610), turning off the EAmodulation for j weeks (block 614), adjusting or tweaking the EAstimulation parameters, if needed (block 622), and repeating the cycleover again starting with block 610.

II. Specific Example II. A. Overview

With the foregoing as a foundation for the general principles andconcepts of the present invention, a specific example of the inventionwill next be described in connection with a description of FIGS. 1-17B.Such specific example teaches one manner in which the general principlesand concepts described above may be applied to one specificelectroacupuncture (EA) device, or IEAD. Although one specific exampleis being described, there are many variations of it that are generallyreferred to in the description of the specific example as “embodiments”.Also, it should be noted that because the description of the specificexample is presented in conjunction with a different set of drawings,FIGS. 1-17B, than were used to describe the general principles andconcepts of the invention, FIGS. 18-31, there will be some differencesin the reference numerals used in connection with one set of drawingsrelative to the reference numerals used in connection with the other setof drawings to describe the same or similar elements. However, suchdifferent reference numerals should not be a source of confusion becausethe context of how and where the references numerals are presented willclearly identify what part or element is being referenced.

The EA device of this specific example is an implantable, coin-shaped,self-contained, symmetrical, leadless electroacupuncture (EA) devicehaving at least two electrode contacts mounted on the surface of itshousing. In one preferred embodiment, the electrodes include a centralcathode electrode on a front side of the housing, and an annular anodeelectrode that surrounds the cathode. In another preferred embodiment,the anode annular electrode is a ring electrode placed around theperimeter edge of the coin-shaped housing.

The EA device is leadless. This means there are no leads or electrodesat the distal end of leads (common with most implantable electricalstimulators) that have to be positioned and anchored at a desiredstimulation site. Also, because there are no leads, no tunneling throughbody tissue is required in order to provide a path for the leads toreturn and be connected to a tissue stimulator (also common with mostelectrical stimulators).

The EA device is adapted to be implanted through a very small incision,e.g., less than 2-3 cm in length, directly adjacent to a selectedacupuncture site (“acupoint”) known to moderate or affect body weight,fat or lipid profile.

The EA device is relatively easy to implant. Also, most embodiments aresymmetrical. This means that there is no way that it can be implantedincorrectly. The basic implant procedure involves cutting an incision,forming an implant pocket, and sliding the device in place through theincision. Only minor, local anesthesia need be used. No major orsignificant complications are envisioned for the implant procedure. TheEA device can also be easily and quickly explanted, if needed.

The EA device is self-contained. It includes a primary battery toprovide its operating power. It includes all of the circuitry it needs,in addition to the battery, to allow it to perform its intended functionfor several years. Once implanted, the patient will not even know it isthere, except for a slight tingling that may be felt when the device isdelivering stimulus pulses during a stimulation session. Also, onceimplanted, the patient can just forget about it. There are nocomplicated user instructions that must be followed. Just turn it on. Nomaintenance is needed. Moreover, should the patient want to disable theEA device, i.e., turn it OFF, or change stimulus intensity, he or shecan easily do so using, e.g., an external magnet.

The EA device can operate for several years because it is designed to bevery efficient. Stimulation pulses applied by the EA device at aselected acupoint through its electrodes formed on its case are appliedat a very low duty cycle in accordance with a specified stimulationregimen. The stimulation regimen applies EA stimulation during astimulation session that lasts at least 10 minutes, typically 30minutes, and rarely longer than 70 minutes. These stimulation sessions,however, occur at a very low duty cycle. In one preferred treatmentregimen, for example, a stimulation session having a duration of 60minutes is applied to the patient just once every seven days. Thestimulation regimen, and the selected acupoint at which the stimulationis applied, are designed and selected to provide efficient and effectiveEA stimulation for the treatment of the patient's dyslipidemia orobesity (e.g., high cholesterol).

The EA device is, compared to most implantable medical devices,relatively easy to manufacture and uses few components. This not onlyenhances the reliability of the device, but helps keep the manufacturingcosts low, which in turn allows the device to be more affordable to thepatient. One key feature included in the mechanical design of the EAdevice is the use of a radial feed-through assembly to connect theelectrical circuitry inside of its housing to one of the electrodes onthe outside of the housing. The design of this radial feed-through pinassembly greatly simplifies the manufacturing process. The processplaces the temperature sensitive hermetic bonds used in the assembly—thebond between a pin and an insulator and the bond between the insulatorand the case wall—away from the perimeter of the housing as the housingis hermetically sealed at the perimeter with a high temperature laserwelding process, thus preserving the integrity of the hermetic bondsthat are part of the feed-through assembly.

In operation, the EA device is safe to use. There are no horrificfailure modes that could occur. Because it operates at a very low dutycycle (i.e., it is OFF much, much more than it is ON), it generateslittle heat. Even when ON, the amount of heat it generates is not much,less than 1 mW, and is readily dissipated. Should a component or circuitinside of the EA device fail, the device will simply stop working. Ifneeded, the EA device can then be easily explanted.

Another key feature included in the design of the EA device is the useof a commercially-available battery as its primary power source. Small,thin, disc-shaped batteries, also known as “coin cells,” are quitecommon and readily available for use with most modern electronicdevices. Such batteries come in many sizes, and use variousconfigurations and materials. However, insofar as applicants are aware,such batteries have never been used in implantable medical devicespreviously. This is because their internal impedance is, or has alwaysthought to have been, much too high for such batteries to be ofpractical use within an implantable medical device where powerconsumption must be carefully monitored and managed so that the device'sbattery will last as long as possible, and so that dips in the batteryoutput voltage (caused by any sudden surge in instantaneous batterycurrent) do not occur that could compromise the performance of thedevice. Furthermore, the energy requirements of other active implantabletherapies are far greater than can be provided by such coin cellswithout frequent replacement.

The EA device of this specific example advantageously employspower-monitoring and power-managing circuits that prevent any suddensurges in battery instantaneous current, or the resulting drops inbattery output voltage, from ever occurring, thereby allowing a wholefamily of commercially-available, very thin, high-output-impedance,relatively low capacity, small disc batteries (or “coin cells”) to beused as the EA device's primary battery without compromising the EAdevice's performance. As a result, instead of specifying that the EAdevice's battery must have a high capacity, e.g., greater than 200 mAh,with an internal impedance of, e.g., less than 5 ohms, which wouldeither require a thicker battery and/or preclude the use ofcommercially-available coin-cell batteries, the EA device of the presentinvention can readily employ a battery having a relatively low capacity,e.g., less than 60 mAh, and a high battery impedance, e.g., greater than5 ohms.

Moreover, the power-monitoring, power-managing, as well as the pulsegeneration, and control circuits used within the EA device arerelatively simple in design, and may be readily fashioned fromcommercially-available integrated circuits (IC's) orapplication-specific integrated circuits (ASIC's), supplemented withdiscrete components, as needed. In other words, the electronic circuitsemployed within the EA device need not be complex nor expensive, but aresimple and inexpensive, thereby making it easier to manufacture the EAdevice and to provide it to patients at an affordable cost.

II. B. Illnesses Addressed, Stimulation Sites and Regimen

The EA device of this specific example is aimed at treating dyslipidemiaor obesity. This it does by applying EA stimulation pulses to at leastone of acupoints ST36, SP4, ST37, ST40, SP6, SP9, KI6, LR8, or certainunderlying nerves, e.g., the peroneal and saphenous nerves, inaccordance with a specific stimulation regimen.

Duration of a stimulation session will typically be about 30 minutes,but could be as short as about 10 minutes and as long as about 70minutes. The time between stimulation sessions (or the rate ofoccurrence of the stimulation session) may be as short as twenty-fourhours and as long as two weeks. The duty cycle of the stimulationsessions, T3/T4, should never be allowed to be greater than 0.05, whereT3 is the duration of the stimulation session, and T4 is the time periodbetween the start of one stimulation session and the beginning of thenext stimulation session.

By way of example, if T3 is 60 minutes, and T4 is 2 weeks (10,080minutes), then the duty cycle is 60/10,080=0.006 (a very low stimulationsession duty cycle). If T3 is 60 minutes and T4 is 1 day (24 hours, or1440 minutes), then the duty cycle is 60/1440=0.042 (still, a very lowsession duty cycle, but approaching the duty cycle limit of 0.05).

The amplitude of stimulation is adjustable and is set to a comfortablelevel depending upon the particular patient. Ideally, the patient willfeel or sense the stimulation as a slight tingling sensation at theacupoint location where the EA stimulation is applied. If the tinglingsensation becomes uncomfortable, then the intensity (e.g., amplitude) ofthe EA stimulation pulses should be decreased until the sensation iscomfortable. Typically, the amplitude of the stimulation pulses may beset to be as low as 1-2 mA and as high as 10-12 mA.

The frequency of the EA stimulation pulses should be nominally 2 Hz, butcould be as low as 1 Hz and as high as 15 Hz.

The width of the EA stimulation pulses is about 0.5 millisecond, butcould be as short as 0.1 millisecond (100 microseconds), or as long as 2millisecond (2000 microseconds), or longer. The duty cycle of theapplied EA stimulation pulses, T1/T2, during a stimulation session islimited to no more than 0.05, where T1 is the width of a stimulationpulse and T2 is the time period between the beginning of one stimulationpulse and the beginning of the next stimulation pulse. By way ofexample, if T1 is 0.5 milliseconds, and T2 is 0.5 seconds (500milliseconds, providing a rate of 2 Hz), then the duty cycle of thestimulus pulses during a stimulation session is 0.5/500=0.001 (a verylow stimulus duty cycle).

II. C. Definitions

As used herein, “annular”, “circumferential”, “circumscribing”,“surrounding” or similar terms used to describe an electrode orelectrode array, or electrodes or electrode arrays, (where the phrase“electrode or electrode array,” or “electrodes or electrode arrays,” isalso referred to herein as “electrode/array,” or “electrodes/arrays,”respectively) refers to an electrode/array shape or configuration thatsurrounds or encompasses a point or object, such as another electrode,without limiting the shape of the electrode/array or electrodes/arraysto be circular or round. In other words, an “annular” electrode/array(or a “circumferential” electrode/array, or a “circumscribing”electrode/array, or a “surrounding” electrode/array), as used herein,may be many shapes, such as oval, polygonal, starry, wavy, and the like,including round or circular.

“Nominal” or “about” when used with a mechanical dimension, e.g., anominal diameter of 23 mm, means that there is a tolerance associatedwith that dimension of no more than plus or minus (+/−) 5%. Thus, adimension that is nominally 23 mm means a dimension of 23 mm+/−(0.05×23mm=1.15 mm).

“Nominal” when used to specify a battery voltage is the voltage by whichthe battery is specified and sold. It is the voltage you expect to getfrom the battery under typical conditions, and it is based on thebattery cell's chemistry. Most fresh batteries will produce a voltageslightly more than their nominal voltage. For example, a new nominal 3volt lithium coin-sized battery will measure more than 3.0 volts, e.g.,up to 3.6 volts under the right conditions. Since temperature affectschemical reactions, a fresh warm battery will have a greater maximumvoltage than a cold one. For example, as used herein, a “nominal 3 volt”battery voltage is a voltage that may be as high as 3.6 volts when thebattery is brand new, but is typically between 2.7 volts and 3.4 volts,depending upon the load applied to the battery (i.e., how much currentis being drawn from the battery) when the measurement is made and howlong the battery has been in use.

II. D. Mechanical Design

Turing first to FIG. 1, there is shown a perspective view of onepreferred embodiment of an implantable electroacupuncture device (IEAD)100 that may be used to treat dyslipidemia or obesity in accordance withthe teachings disclosed herein. The IEAD 100 may also sometimes bereferred to as an implantable electroacupuncture stimulator (IEAS). Asseen in FIG. 1, the IEAD 100 has the appearance of a disc or coin,having a front side 102, a backside 106 (not visible in FIG. 1) and anedge side 104.

As used herein, the “front” side of the IEAD 100 is the side that ispositioned so as to face the target stimulation point (e.g., the desiredacupoint) where EA is to be applied when the IEAD is implanted. The“back” side is the side opposite the front side and is the farthest awayfrom the target stimulation point when the IEAD is implanted. The “edge”of the IEAD is the side that connects or joins the front side to theback side. In FIG. 1, the IEAD 100 is oriented to show the front side102 and a portion of the edge side 104.

Many of the features associated with the mechanical design of the IEAD100 shown in FIG. 1 are the subject of a prior U.S. Provisional Patentapplication, entitled “Radial Feed-Through Packaging for An ImplantableElectroacupuncture Device”, Application No. 61/676,275, filed 26 Jul.2012, which application is incorporated here by reference.

It should be noted here that throughout this application, the terms IEAD100, IEAD housing 100, bottom case 124, can 124, or IEAD case 124, orsimilar terms, are used to describe the housing structure of the EAdevice. In some instances it may appear these terms are usedinterchangeably. However, the context should dictate what is meant bythese terms. As the drawings illustrate, particularly FIG. 7, there is abottom case 124 that comprises the “can” or “container” wherein thecomponents of the IEAD 100 are first placed and assembled duringmanufacture of the IEAD 100. When all of the components are assembledand placed within the bottom case 124, a cover plate 122 is welded tothe bottom case 124 to form the hermetically-sealed housing of the IEAD.The cathode electrode 110 is attached to the outside of the bottom case124 (which is the front side 102 of the device), and the ring anodeelectrode 120 is attached, along with its insulating layer 129, aroundthe perimeter edge 104 of the bottom case 124. Finally, a layer ofsilicone molding 125 covers the IEAD housing except for the outsidesurfaces of the anode ring electrode and the cathode electrode.

The embodiment of the IEAD 100 shown in FIG. 1 utilizes two electrodes,a cathode electrode 110 that is centrally positioned on the front side102 of the IEAD 100, and an anode electrode 120. The anode electrode 120is a ring electrode that fits around the perimeter edge 104 of the IEAD100. Not visible in FIG. 1, but which is described hereinafter inconnection with the description of FIG. 7, is a layer of insulatingmaterial 129 that electrically insulates the anode ring electrode 120from the perimeter edge 104 of the housing or case 124.

Not visible in FIG. 1, but a key feature of the mechanical design of theIEAD 100, is the manner in which an electrical connection is establishedbetween the ring electrode 120 and electronic circuitry carried insideof the IEAD 100. This electrical connection is established using aradial feed-through pin that fits within a recess formed in a segment ofthe edge of the case 124, as explained more fully below in connectionwith the description of FIGS. 5, 5A, 5B and 7.

In contrast to the feed-through pin that establishes electrical contactwith the anode electrode, electrical connection with the cathodeelectrode 110 is established simply by forming or attaching the cathodeelectrode 110 to the front surface 102 of the IEAD case 124. In order toprevent the entire case 124 from functioning as the cathode (which isdone to better control the electric fields established between the anodeand cathode electrodes), the entire IEAD housing is covered in a layerof silicone molding 125 (see FIG. 7), except for the outside surface ofthe anode ring electrode 120 and the cathode electrode 110.

The advantage of using a central cathode electrode and a ring anodeelectrode is described in U.S. Provisional Patent Application No.61/672,257, filed 6 Mar. 2012, entitled “Electrode Configuration forImplantable Electroacupuncture Device”, which application isincorporated herein by reference. One significant advantage of thiselectrode configuration is that it is symmetrical. That is, whenimplanted, the surgeon or other medical personnel performing the implantprocedure, need only assure that the cathode side of the IEAD 100, which(for the embodiment shown in FIGS. 1-7) is the front side of the device,facing the target tissue location that is to be stimulated.

In this regard, it should be noted that while the target stimulationpoint is generally identified by an “acupoint,” which is typically shownin drawings and diagrams as residing on the surface of the skin, thesurface of the skin is not the actual target stimulation point. Rather,whether such stimulation comprises manual manipulation of a needleinserted through the skin at the location on the skin surface identifiedas an “acupoint”, or whether such stimulation comprises electricalstimulation applied through an electrical field oriented to causestimulation current to flow through the tissue at a prescribed depthbelow the acupoint location on the skin surface, the actual targettissue point to be stimulated is located beneath the skin at a depththat varies depending on the particular acupoint location. Whenstimulation is applied at the target tissue point, such stimulation iseffective at treating a selected condition of the patient, e.g., highcholesterol, because there is something in the tissue at that location,or near that location, such as a nerve, a tendon, a muscle, or othertype of tissue, that responds to the applied stimulation in a mannerthat contributes favorably to the treatment of the condition experiencedby the patient.

For purposes of the present application, some of the target acupointsare located near a bone of the patient. When the bone is very close tothe skin surface, the location of the bone may prevent deep tissuestimulation, and may even prevent or hamper implantation at a desireddepth. This condition—of having a bone near the skin surface—isillustrated schematically in FIGS. 17A and 17B. As seen in thesefigures, the bone is shown generally as being right under the skin 80,with not much tissue separating the two. These two figures assume thatthe actual desired target stimulation point is below acupoint 90 at anerve 87 (or some other tissue formation) between the underneath side ofthe skin 80 and the top surface of the bone 89. Hence, the challenge isto implant the IEAD 100 in a manner that provides effective EAstimulation at the desired target stimulation site, e.g., at the nerve87 (or other target tissue formation) that resides beneath the acupoint90. FIGS. 17A and 17B illustrate alternative methods for achieving thisgoal.

Shown in FIG. 17A is one alternative for implanting the IEAD 100 at anacupoint 90 located on the surface of the skin 80 above a bone 89, wherethe actual target stimulation point is a nerve 87, or some other tissueformation, that is located between the bone 89 and the underneath sideof the skin 80. As shown in FIG. 17A, the IEAD 100 is implanted rightunder the skin with its front surface 102 facing down towards the targettissue location 87. This allows the electric fields (illustrated by theelectric field gradient lines 88) generated by the IEAD 100 when EAstimulation pulses are to be generated to be most heavily concentratedat the target tissue stimulation site 87. These electric field gradientlines 88 are established between the two electrodes 110 and 120 of theIEAD. For the embodiment shown here, these two electrodes comprise aring electrode 120, positioned around the perimeter edge of the IEADhousing, and a central electrode 110, positioned in the center of thefront surface 102 of the IEAD housing. These gradient lines 88 are mostconcentrated right below the central electrode, which is where thetarget tissue location 87 resides. Hence, the magnitude of theelectrical stimulation current will also be most concentrated at thetarget tissue location 87, which is the desired result.

FIG. 17B shows another alternative for implanting the IEAD 100 at theacupoint 90 located on the surface of the skin 80 above the bone 89,where the actual target stimulation point is a nerve 87, or some othertissue formation, that is located between the bone 89 and the underneathside of the skin 80. As shown in FIG. 17B, the IEAD 100 is implanted ina pocket 81 formed in the bone 89 at a location underneath the acupoint90. In this instance, and as the elements are oriented in FIG. 17B, thefront surface 102 of the IEAD 100 faces upwards towards the targettissue location 87. As with the implant configuration shown in FIG. 17A,this configuration also allows the electric fields (illustrated by theelectric field gradient lines 88) that are generated by the IEAD 100when EA stimulation pulses are generated to be most heavily concentratedat the target tissue stimulation site 87.

There are advantages and disadvantages associated with each of the twoalternative implantation configurations shown in FIGS. 17A and 17B.Generally, the implantation procedure used to achieve the configurationshown in FIG. 17A is a simpler procedure with fewer risks. That is, allthat need to be done by the surgeon to implant that EA device 100 asshown in FIG. 17A is to make an incision 82 in the skin 80 a shortdistance, e.g., 10-15 mm, away from the acupoint 90. This incisionshould be made parallel to the nerve 87 so as to minimize the risk ofcutting the nerve 87. A slot is then formed at the incision by liftingthe skin closest to the acupoint up at the incision and by carefullysliding the IEAD 100, with its front side 102 facing the bone, into theslot so that the center of the IEAD is located under the acupoint 90.Care is taken to assure that the nerve 87 resides below the frontsurface of the IEAD 100 as the IEAD is slid into position.

In contrast, if the implant configuration shown in FIG. 17B is to beused, then the implant procedure is somewhat more complicated withsomewhat more risks. That is, to achieve the implant configuration shownin FIG. 17B, a sufficiently large incision must be made in the skin atthe acupoint 90 to enable the skin 80 to be peeled or lifted away toexpose the surface of the skull so that the cavity 81 may be formed inthe bone 89. While doing this, care must be exercised to hold the nerve87 (or other sensitive tissue areas) away from the cutting tools used toform the cavity 81. Once the cavity 81 is formed, the IEAD 100 is laidin the cavity, with its front surface facing upward, the nerve 87 (andother sensitive tissue areas) are carefully repositioned above the IEAD100, and the skin is sewn or clamped to allow the incision to heal.

However, while the surgical procedure and attendant risks may be morecomplicated when the configuration of FIG. 17B is employed, the finalresults of the configuration of FIG. 17B may be more aestheticallypleasing to the patient than are achieved with the configuration of FIG.17A. That is, given the shallow space between the skin and the bone at adesired acupoints, the implant configuration of FIG. 17A will likelyresult in a small hump or bump at the implant site.

Insofar as Applicant is aware at the present time, of the two implantconfigurations shown in FIGS. 17A and 17B, there is no theoreticalperformance advantage that one implant configuration provides over theother. That is, both implant configurations should perform equally wellinsofar as providing EA stimulation pulses at the desired target tissuelocation 87 is concerned.

Thus, which implant configuration is used will, in large part, bedictated by individual differences in patient anatomy, patientpreference, and surgeon preferences and skill levels.

From the above, it is seen that one of the main advantages of using asymmetrical electrode configuration that includes a centrally locatedelectrode surrounded by an annular electrode, as is used in theembodiment described in connection with FIGS. 1-7, is that the preciseorientation of the IEAD 100 within its implant location is notimportant. So long as one electrode faces and is centered over (orunder) the desired target location, and the other electrode surroundsthe first electrode (e.g., as an annular electrode), a strong electricfield gradient is created that is aligned with the desired target tissuelocation. This causes the EA stimulation current to flow at (or verynear to) the target tissue location 87.

Turning next to FIG. 2, there is shown a plan view of the “front” sideof the IEAD 100. As seen in FIG. 2, the cathode electrode 110 appears asa circular electrode, centered on the front side, having a diameter D1.The IEAD housing has a diameter D2 and an overall thickness or width W2.For the preferred embodiment shown in these figures, D1 is about 4 mm,D2 is about 23 mm and W2 is a little over 2 mm (2.2 mm).

FIG. 2A shows a side view of the IEAD 100. The ring anode electrode 120,best seen in FIG. 2A, has a width W1 of about 1.0 mm, or approximately ½of the width W2 of the IEAD.

FIG. 3 shows a plan view of the “back” side of the IEAD 100. As will beevident from subsequent figure descriptions, e.g., FIGS. 5A and 5B, theback side of the IEAD 100 comprises a cover plate 122 that is welded inplace once the bottom case 124 has all of the electronic circuitry, andother components, placed inside of the housing.

FIG. 3A is a sectional view of the IEAD 100 of FIG. 1 taken along theline A-A of FIG. 3. Visible in this sectional view is the feed-throughpin 130, including the distal end of the feed-through pin 130 attachedto the ring anode electrode 120. Also visible in this section view is anelectronic assembly 133 on which various electronic components aremounted, including a disc-shaped battery 132. FIG. 3A furtherillustrates how the cover plate 122 is welded, or otherwise bonded, tothe bottom case 124 in order to form the hermetically-sealed IEADhousing 100.

FIG. 4 shows a perspective view of the IEAD case 124, including thefeed-through pin 130, before the electronic components are placedtherein, and before being sealed with the “skin side” cover plate 122.The case 124 is similar to a shallow “can” without a lid, having a shortside wall around its perimeter. Alternatively, the case 124 may beviewed as a short cylinder, closed at one end but open at the other.(Note, in the medical device industry the housing of an implanted deviceis often referred to as a “can”.) The feed-through pin 130 passesthrough a segment of the wall of the case 124 that is at the bottom of arecess 140 formed in the wall. The use of this recess 140 to hold thefeed-through pin 130 is a key feature of the invention because it keepsthe temperature-sensitive portions of the feed-through assembly (thoseportions that could be damaged by excessive heat) away from the thermalshock and residual weld stress inflicted upon the case 124 when thecover plate 122 is welded thereto.

FIG. 4A is a side view of the IEAD case 124, and shows an annular rim126 formed on both sides of the case 124. The ring anode electrode 120fits between these rims 126 once the ring electrode 120 is positionedaround the edge of the case 124. (This ring electrode 120 is, for mostconfigurations, used as an anode electrode. Hence, the ring electrode120 may sometimes be referred to herein as a ring anode electrode.However, it is noted that the ring electrode could also be employed as acathode electrode, if desired.) A silicone insulator layer 129 (see FIG.7) is placed between the backside of the ring anode electrode 120 andthe perimeter edge of the case 124 where the ring anode electrode 120 isplaced around the edge of the case 124.

FIG. 5 shows a plan view of the empty IEAD case 124 shown in theperspective view of FIG. 4. An outline of the recess cavity 140 is alsoseen in FIG. 5, as is the feed-through pin 130. A bottom edge of therecess cavity 140 is located a distance D5 radially inward from the edgeof the case 124. In one embodiment, the distance D5 is between about 2.0to 2.5 mm. The feed-through pin 130, which is just a piece of solidwire, is shown in FIG. 5 extending radially outward from the case 124above the recess cavity 140 and radially inward from the recess cavitytowards the center of the case 124. The length of this feed-through pin130 is trimmed, as needed, when a distal end (extending above therecess) is connected (welded) to the anode ring electrode 120 (passingthrough a hole in the ring electrode 120 prior to welding) and when aproximal end of the feed-through pin 130 is connected to an outputterminal of the electronic assembly 133.

FIG. 5A depicts a sectional view of the IEAD housing 124 of FIG. 5 takenalong the section line A-A of FIG. 5. FIG. 5B shows an enlarged view ordetail of the portion of FIG. 5A that is encircled with the line B.Referring to FIGS. 5A and 5B jointly, it is seen that the feed-throughpin 130 is embedded within an insulator material 136, which insulatingmaterial 136 has a diameter of D3. The feed-through pin assembly (whichpin assembly comprises the combination of the pin 130 embedded into theinsulator material 136) resides on a shoulder around an opening or holeformed in the bottom of the recess 140 having a diameter D4. For theembodiment shown in FIGS. 5A and 5B, the diameter D3 is 0.95-0.07 mm,where the −0.07 mm is a tolerance. (Thus, with the tolerance considered,the diameter D3 may range from 0.88 mm to 0.95 mm) The diameter D4 is0.80 mm with a tolerance of −0.06 mm. (Thus, with the toleranceconsidered, the diameter D4 could range from 0.74 mm to 0.80 mm).

The feed-through pin 130 is preferably made of pure platinum 99.95%. Apreferred material for the insulator material 136 is Ruby or alumina.The IEAD case 124, and the cover 122, are preferably made from titanium.The feed-through assembly, including the feed-through pin 130,ruby/alumina insulator 136 and the case 124 are hermetically sealed as aunit by gold brazing. Alternatively, active metal brazing can be used.(Active metal brazing is a form of brazing which allows metal to bejoined to ceramic without metallization.)

The hermeticity of the sealed IEAD housing is tested using a helium leaktest, as is common in the medical device industry. The helium leak rateshould not exceed 1×10⁻⁹ STD cc/sec at 1 atm pressure. Other tests areperformed to verify the case-to-pin resistance (which should be at least15×10⁶ Ohms at 100 volts DC), the avoidance of dielectric breakdown orflashover between the pin and the case 124 at 400 volts AC RMS at 60 Hzand thermal shock.

One important advantage provided by the feed-through assembly shown inFIGS. 4A, 5, 5A and 5B is that the feed-through assembly made from thefeed-through pin 130, the ruby insulator 136 and the recess cavity 140(formed in the case material 124) may be fabricated and assembled beforeany other components of the IEAD 100 are placed inside of the IEAD case124. This advantage greatly facilitates the manufacture of the IEADdevice.

Turning next to FIG. 6, there is shown a perspective view of anelectronic assembly 133. The electronic assembly 133 includes amulti-layer printed circuit (pc) board 138, or equivalent mountingstructure, on which a battery 132 and various electronic components 134are mounted. This assembly is adapted to fit inside of the empty bottomhousing 124 of FIG. 4 and FIG. 5.

FIGS. 6A and 6B show a plan view and side view, respectively, of theelectronic assembly 133 shown in FIG. 6. The electronic components areassembled and connected together so as to perform the circuit functionsneeded for the IEAD 100 to perform its intended functions. These circuitfunctions are explained in more detail below under the sub-heading“Electrical Design”. Additional details associated with these functionsmay also be found in many of the co-pending patent applicationsreferenced above.

FIG. 7 shows an exploded view of the complete IEAD 100, illustrating itsmain constituent parts. As seen in FIG. 7, the IEAD 100 includes,starting on the right and going left, a cathode electrode 110, a ringanode electrode 120, an insulating layer 129, the bottom case 124 (the“can” portion of the IEAD housing, and which includes the feed-throughpin 130 which passes through an opening in the bottom of the recess 140formed as part of the case, but wherein the feed-through pin 130 isinsulated and does not make electrical contact with the metal case 124by the ruby insulator 136), the electronic assembly 133 (which includesthe battery 132 and various electronic components 134 mounted on a pcboard 138) and the cover plate 122. The cover plate 122 is welded to theedge of the bottom case 124 using laser beam welding, or some equivalentprocess, as one of the final steps in the assembly process.

Other components included in the IEAD assembly, but not necessarilyshown or identified in FIG. 7, include adhesive patches for bonding thebattery 132 to the pc board 138 of the electronic assembly 133, and forbonding the electronic assembly 133 to the inside of the bottom of thecase 124. To prevent high temperature exposure of the battery 132 duringthe assembly process, conductive epoxy is used to connect a batteryterminal to the pc board 138. Because the curing temperature ofconductive epoxy is 125° C., the following process is used: (a) firstcure the conductive epoxy of a battery terminal ribbon to the pc boardwithout the battery, (b) then glue the battery to the pc board usingroom temperature cure silicone, and (c) laser tack weld the connectingribbon to the battery.

Also not shown in FIG. 7 is the manner of connecting the proximal end ofthe feed-through pin 130 to the pc board 138, and connecting a pc boardground pad to the case 124. A preferred method of making theseconnections is to use conductive epoxy and conductive ribbons, althoughother connection methods known in the art may also be used.

Further shown in FIG. 7 is a layer of silicon molding 125 that is usedto cover all surfaces of the entire IEAD 100 except for the anode ringelectrode 120 and the circular cathode electrode 110. An overmoldingprocess is used to accomplish this, although overmolding using siliconeLSR 70 (curing temperature of 120° C.) with an injection moldlingprocess cannot be used. Overmolding processes that may be used include:(a) molding a silicone jacket and gluing the jacket onto the case usingroom temperature cure silicone (RTV) inside of a mold, and curing atroom temperature; (b) injecting room temperature cure silicone in a PEEKor Teflon® mold (silicone will not stick to the Teflon® or PEEKmaterial); or (c) dip coating the IEAD 100 in room temperature curesilicone while masking the electrode surfaces that are not to be coated.(Note: PEEK is a well known semicrystalline thermoplastic with excellentmechanical and chemical resistance properties that are retained at hightemperatures.)

When assembled, the insulating layer 129 is positioned underneath thering anode electrode 120 so that the anode electrode does not short tothe case 124. The only electrical connection made to the anode electrode120 is through the distal tip of the feed-through pin 130. Theelectrical contact with the cathode electrode 110 is made through thecase 124. However, because the entire IEAD is coated with a layer ofsilicone molding 125, except for the anode ring electrode 120 and thecircular cathode electrode 110, all stimulation current generated by theIEAD 100 must flow between the exposed surfaces of the anode andcathode.

It is noted that while the preferred configuration described herein usesa ring anode electrode 120 placed around the edges of the IEAD housing,and a circular cathode electrode 110 placed in the center of the cathodeside of the IEAD case 124, such an arrangement could be reversed, i.e.,the ring electrode could be the cathode, and the circular electrodecould be the anode.

Moreover, the location and shape of the electrodes may be configureddifferently than is shown in the one preferred embodiment describedabove in connection with FIGS. 1, and 2-7. For example, the ring anodeelectrode 120 need not be placed around the perimeter of the device, butsuch electrode may be a flat circumferential electrode that assumesdifferent shapes (e.g., round or oval) that is placed on the front orback surface of the IEAD so as to surround the central electrode.Further, for some embodiments, the surfaces of the anode and cathodeelectrodes may have convex surfaces.

It is also noted that while one preferred embodiment has been disclosedherein that incorporates a round, or short cylindrical-shaped housing,also referred to as a coin-shaped housing, the invention does notrequire that the case 124 (which may also be referred to as a“container”), and its associated cover plate 122, be round. The casecould just as easily be an oval-shaped, rectangular-shaped (e.g., squarewith smooth corners), polygonal-shaped (e.g., hexagon-, octagon-,pentagon-shaped), button-shaped (with convex top or bottom for asmoother profile) device. Some particularly attractive alternate caseshapes, and electrode placement on the surfaces of those case shapes,are illustrated in Appendix E. Any of these alternate shapes, or others,would still permit the basic principles of the invention to be used toprovide a robust, compact, thin, case to house the electronic circuitryand power source used by the invention; as well as to help protect afeed-through assembly from being exposed to excessive heat duringassembly, and to allow the thin device to provide the benefits describedherein related to its manufacture, implantation and use. For example, aslong as the device remains relatively thin, e.g., no more than about 2-3mm, and does not have a maximum linear dimension greater than about 25mm, then the device can be readily implanted in a pocket over the tissuearea where the selected acupuoint(s) is located. As long as there is arecess in the wall around the perimeter of the case wherein thefeed-through assembly may be mounted, which recess effectively moves thewall or edge of the case inwardly into the housing a safe thermaldistance, as well as a safe residual weld stress distance, from theperimeter wall where a hermetically-sealed weld occurs, the principlesof the invention apply.

Further, it should be noted that while the preferred configuration ofthe IEAD described herein utilizes a central electrode on one of itssurfaces that is round, having a diameter of nominally 4 mm, suchcentral electrode need not necessarily be round. It could be ovalshaped, polygonal-shaped, or shaped otherwise, in which case its size isbest defined by its maximum width, which will generally be no greaterthan about 7 mm.

Finally, it is noted that the electrode arrangement may be modifiedsomewhat, and the desired attributes of the invention may still beachieved. For example, as indicated previously, one preferred electrodeconfiguration for use with the invention utilizes a symmetricalelectrode configuration, e.g., an annular electrode of a first polaritythat surrounds a central electrode of a second polarity. Such asymmetrical electrode configuration makes the implantableelectroacupuncture device (IEAD) relatively immune to being implanted inan improper orientation relative to the body tissue at the selectedacupoint(s) that is being stimulated. However, an electrodeconfiguration that is not symmetrical may still be used and many of thetherapeutic effects of the invention may still be achieved. For example,two spaced-apart electrodes on a front surface of the housing, one of afirst polarity, and a second of a second polarity, could still, whenoriented properly with respect to a selected acupoint tissue location,provide some desired therapeutic results

FIG. 7A schematically illustrates a few alternative electrodeconfigurations that may be used with the invention. The electrodeconfiguration schematically shown in the upper left corner of FIG. 7A,identified as “I”, schematically illustrates one central electrode 110surrounded by a single ring electrode 120. This is one of the preferredelectrode configurations that has been described previously inconnection, e.g., with the description of FIGS. 1, 1A, 1B and 7, and ispresented in FIG. 7A for reference and comparative purposes.

In the lower left corner of FIG. 7A, identified as “II”, anelectrode/array configuration is schematically illustrated that has acentral electrode 310 of a first polarity surrounded by an electrodearray 320 a of two electrodes of a second polarity. When the twoelectrodes (of the same polarity) in the electrode array 320 a areproperly aligned with the body tissue being stimulated, e.g., alignedwith a nerve 87 (see FIGS. 17A and 17B), then such electrodeconfiguration can stimulate the body tissue (e.g., the nerve 87) at ornear the desired acupoint(s) with the same, or almost the same, efficacyas can the electrode configuration I (upper right corner of FIG. 7A).

Note, as has already been described above, the phrase “electrode orelectrode array,” or “electrodes or electrode arrays,” may also bereferred to herein as “electrode/array” or “electrodes/arrays,”respectively. For the ease of explanation, when an electrode array isreferred to herein that comprises a plurality (two or more) ofindividual electrodes of the same polarity, the individual electrodes ofthe same polarity within the electrode array may also be referred to as“individual electrodes”, “segments” of the electrode array, “electrodesegments”, or just “segments”.

In the lower right corner of FIG. 7A, identified as “μl”, en electrodeconfiguration is schematically illustrated that has a centralelectrode/array 310 b of three electrode segments of a first polaritysurrounded by an electrode array 320 b of three electrode segments of asecond polarity. As shown in FIG. 7A-III, the three electrode segmentsof the electrode array 320 b are symmetrically positioned within thearray 320 b, meaning that they are positioned more or less equidistantfrom each other. However, a symmetrical positioning of the electrodesegments within the array is not necessary to stimulate the body tissueat the desired acupoint(s) with some efficacy.

In the upper right corner of FIG. 7A, identified as “IV”, anelectrode/array configuration is schematically illustrated that has acentral electrode array 310 c of a first polarity surrounded by anelectrode array 320 c of four electrode segments of a second polarity.The four electrode segments of the electrode array 320 c are arrangedsymmetrically in a round or oval-shaped array. The four electrodesegments of the electrode array 310 b are likewise arrangedsymmetrically in a round or oval-shaped array. While preferred for manyconfigurations, the use of a symmetrical electrode/array, whether as acentral electrode array 310 or as a surrounding electrode/array 320, isnot always required.

The electrode configurations I, II, III and IV shown schematically inFIG. 7A are only representative of a few electrode configurations thatmay be used with the present invention. Further, it is to be noted thatthe central electrode/array 310 need not have the same number ofelectrode segments as does the surrounding electrode/array 320.Typically, the central electrode/array 310 of a first polarity will be asingle electrode; whereas the surrounding electrode/array 320 of asecond polarity may have n individual electrode segments, where n is aninteger that can vary from 1, 2, 3, . . . n. Thus, for a circumferentialelectrode array where n=4, there are four electrode segments of the samepolarity arranged in circumferential pattern around a centralelectrode/array. If the circumferential electrode array with n=4 is asymmetrical electrode array, then the four electrode segments will bespaced apart equally in a circumferential pattern around a centralelectrode/array. When n=1, the circumferential electrode array reducesto a single circumferential segment or a single annular electrode thatsurrounds a central electrode/array.

Additionally, the polarities of the electrode/arrays may be selected asneeded. That is, while the central electrode/array 310 is typically acathode (−), and the surrounding electrode/array 320 is typically ananode (+), these polarities may be reversed.

It should be noted that the shape of the circumferentialelectrode/array, whether circular, oval, or other shape, need notnecessarily be the same shape as the IEAD housing, unless thecircumferential electrode/array is attached to a perimeter edge of theIEAD housing. The IEAD housing may be round, or it may be oval, or itmay have a polygon shape, or other shape, as needed to suit the needs ofa particular manufacturer and/or patient.

Additional electrode configurations, both symmetrical electrodeconfigurations and non-symmetrical electrode configurations, that may beused with an EA stimulation device as described herein, are described inAppendix A and Appendix B.

II. E. Electrical Design

Next, with reference to FIGS. 8A-14, the electrical design and operationof the circuits employed within the IEAD 100 will be described. Moredetails associated with the design of the electrical circuits describedherein may be found in the following previously-filed U.S. Provisionalpatent applications, which applications are incorporated herein byreference: (1) Appl. No. 61/626,339, filed Sep. 23, 2011, entitledImplantable Electroacupuncture Device and Method for TreatingCardiovascular Disease; (2) Appl. No. 61/609,875, filed Mar. 12, 2012,entitled Boost Converter Output Control For ImplantableElectroacupuncture Device; (3) Appl. No. 61/672,257, filed Jul. 16,2012, entitled Boost Converter Circuit Surge Control For ImplantableElectroacupuncture Device Using Digital Pulsed Shutdown; (4) Appl. No.61/672,661, filed Jul. 17, 2012, entitled Smooth Ramp-Up StimulusAmplitude Control For Implantable Electroacupuncture Device; and (5)Appl. No. 61/674,691, filed Jul. 23, 2012, entitled Pulse ChargeDelivery Control In An Implantable Electroacupuncture Device.

FIG. 8A shows a functional block diagram of an implantableelectroacupuncture device (IEAD) 100 made in accordance with theteachings disclosed herein. As seen in FIG. 8A, the IEAD 100 uses animplantable battery 215 having a battery voltage V_(BAT). Also includedwithin the IEAD 100 is a Boost Converter circuit 200, an Output Circuit202 and a Control Circuit 210. The battery 115, boost converter circuit200, output circuit 202 and control circuit 210 are all housed within anhermetically sealed housing 124.

As controlled by the control circuit 210, the output circuit 202 of theIEAD 100 generates a sequence of stimulation pulses that are deliveredto electrodes E1 and E2, through feed-through terminals 206 and 207,respectively, in accordance with a prescribed stimulation regimen. Acoupling capacitor C_(C) is also employed in series with at least one ofthe feed-through terminals 206 or 207 to prevent DC (direct current)current from flowing into the patient's body tissue.

As explained more fully below in connection with the description ofFIGS. 15A and 15B, the prescribed stimulation regimen comprises acontinuous stream of stimulation pulses having a fixed amplitude, e.g.,V_(A) volts, a fixed pulse width, e.g., 0.5 millisecond, and at a fixedfrequency, e.g., 2 Hz, during each stimulation session. The stimulationsession, also as part of the stimulation regimen, is generated at a verylow duty cycle, e.g., for 30 minutes once each week. Other stimulationregimens may also be used, e.g., using a variable frequency for thestimulus pulse during a stimulation session rather than a fixedfrequency.

In one preferred embodiment, the electrodes E1 and E2 form an integralpart of the housing 124. That is, electrode E2 may comprise acircumferential anode electrode that surrounds a cathode electrode E1.The cathode electrode E1, for the embodiment described here, iselectrically connected to the case 124 (thereby making the feed-throughterminal 206 unnecessary).

In a second preferred embodiment, particularly well-suited forimplantable electrical stimulation devices, the anode electrode E2 iselectrically connected to the case 124 (thereby making the feed-throughterminal 207 unnecessary). The cathode electrode E1 is electricallyconnected to the circumferential electrode that surrounds the anodeelectrode E2. That is, the stimulation pulses delivered to the targettissue location (i.e., to the selected acupoint) through the electrodesE1 and E2 are, relative to a zero volt ground (GND) reference, negativestimulation pulses, as shown in the waveform diagram near the lowerright hand corner of FIG. 8A.

Thus, in the embodiment described in FIG. 8A, it is seen that during astimulation pulse the electrode E2 functions as an anode, or positive(+) electrode, and the electrode E1 functions as a cathode, or negative(−) electrode.

The battery 115 provides all of the operating power needed by the EAdevice 100. The battery voltage V_(BAT) is not the optimum voltageneeded by the circuits of the EA device, including the output circuitry,in order to efficiently generate stimulation pulses of amplitude, e.g.,−V_(A) volts. The amplitude V_(A) of the stimulation pulses is typicallymany times greater than the battery voltage V_(BAT). This means that thebattery voltage must be “boosted”, or increased, in order forstimulation pulses of amplitude V_(A) to be generated. Such “boosting”is done using the boost converter circuit 200. That is, it is thefunction of the Boost Converter circuit 200 to take its input voltage,V_(BAT), and convert it to another voltage, e.g., V_(OUT), which voltageV_(OUT) is needed by the output circuit 202 in order for the IEAD 100 toperform its intended function.

The IEAD 100 shown in FIG. 8A, and packaged as described above inconnection with FIGS. 1-7, advantageously provides a tinyself-contained, coin-sized stimulator that may be implanted in a patientat or near a specified acupoint in order to favorably treat a conditionor disease of a patient. The coin-sized stimulator advantageouslyapplies electrical stimulation pulses at very low levels and low dutycycles in accordance with specified stimulation regimens throughelectrodes that form an integral part of the housing of the stimulator.A tiny battery inside of the coin-sized stimulator provides enoughenergy for the stimulator to carry out its specified stimulation regimenover a period of several years. Thus, the coin-sized stimulator, onceimplanted, provides an unobtrusive, needleless, long-lasting, safe,elegant and effective mechanism for treating certain conditions anddiseases that have long been treated by acupuncture orelectroacupuncture.

A boost converter integrated circuit (IC) typically draws current fromits power source in a manner that is proportional to the differencebetween the actual output voltage V_(OUT) and a set point outputvoltage, or feedback signal. A representative boost converter circuitthat operates in this manner is shown in FIG. 8B. At boost converterstart up, when the actual output voltage is low compared to the setpoint output voltage, the current drawn from the power source can bequite large. Unfortunately, when batteries are used as power sources,they have internal voltage losses (caused by the battery's internalimpedance) that are proportional to the current drawn from them. Thiscan result in under voltage conditions when there is a large currentdemand from the boost converter at start up or at high instantaneousoutput current. Current surges and the associated under voltageconditions can lead to undesired behavior and reduced operating life ofan implanted electro-acupuncture device.

In the boost converter circuit example shown in FIG. 8A, the battery ismodeled as a voltage source with a simple series resistance. Withreference to the circuit shown in FIG. 8A, when the series resistanceR_(BAT) is small (5 Ohms or less), the boost converter input voltageV_(IN), output voltage V_(OUT) and current drawn from the battery,I_(BAT), typically look like the waveform shown in FIG. 9A, where thehorizontal axis is time, and the vertical axis on the left is voltage,and the vertical axis of the right is current.

Referring to the waveform in FIG. 9A, at boost converter startup (10ms), there is 70 mA of current drawn from the battery with only ˜70 mVof drop in the input voltage V_(IN). Similarly, the instantaneous outputcurrent demand for electro-acupuncture pulses draws up to 40 mA from thebattery with an input voltage drop of ˜40 mV.

Disadvantageously, however, a battery with higher internal impedance(e.g., 160 Ohms), cannot source more than a milliampere or so of currentwithout a significant drop in output voltage. This problem is depictedin the timing waveform diagram shown in FIG. 9B. In FIG. 9B, as in FIG.9A, the horizontal axis is time, the left vertical axis is voltage, andthe right vertical axis is current.

As seen in FIG. 9B, as a result of the higher internal batteryimpedance, the voltage at the battery terminal (V_(IN)) is pulled downfrom 2.9 V to the minimum input voltage of the boost converter (˜1.5 V)during startup and during the instantaneous output current loadassociated with electro-acupuncture stimulus pulses. The resulting dropsin output voltage V_(OUT) are just not acceptable in any type of circuitexcept an uncontrolled oscillator circuit.

Also, it should be noted that although the battery used in the boostconverter circuit is modeled in FIG. 8B as a simple series resistor,battery impedance can arise from the internal design, battery electrodesurface area and different types of electrochemical reactions. All ofthese contributors to battery impedance can cause the voltage of thebattery at the battery terminals to decrease as the current drawn fromthe battery increases.

In a suitably small and thin implantable electroacupuncture device(IEAD) of the type disclosed herein, it is desired to use a higherimpedance battery in order to assure a small and thin device, keep costslow, and/or to have low self-discharge rates. The battery internalimpedance also typically increases as the battery discharges. This canlimit the service life of the device even if a new battery hasacceptably low internal impedance. Thus, it is seen that for the IEAD100 disclosed herein to reliably perform its intended function over along period of time, a circuit design is needed for the boost convertercircuit that can manage the instantaneous current drawn from V_(IN) ofthe battery. Such current management is needed to prevent the battery'sinternal impedance from causing V_(IN) to drop to unacceptably lowlevels as the boost converter circuit pumps up the output voltageV_(OUT) and when there is high instantaneous output current demand, asoccurs when EA stimulation pulses are generated.

To provide this needed current management, the IEAD 100 disclosed hereinemploys electronic circuitry as shown in FIG. 10, or equivalentsthereof. Similar to what is shown in FIG. 8B, the circuitry of FIG. 10includes a battery, a boost converter circuit 200, an output circuit230, and a control circuit 220. The control circuit 220 generates adigital control signal that is used to duty cycle the boost convertercircuit 200 ON and OFF in order to limit the instantaneous current drawnfrom the battery. That is, the digital control signal pulses the boostconverter ON for a short time, but then shuts the boost converter downbefore a significant current can be drawn from the battery. Inconjunction with such pulsing, an input capacitance CF is used to reducethe ripple in the input voltage V_(IN). The capacitor CF supplies thehigh instantaneous current for the short time that the boost converteris ON and then recharges more slowly from the battery during theinterval that the boost converter is OFF.

In the circuitry shown in FIG. 10, it is noted that the output voltageV_(OUT) generated by the boost converter circuit 200 is set by thereference voltage V_(REF) applied to the set point or feedback terminalof the boost converter circuit 200. For the configuration shown in FIG.10, V_(REF) is proportional to the output voltage V_(OUT), as determinedby the resistor dividing network of R1 and R2.

The switches S_(P) and S_(R), shown in FIG. 10 as part of the outputcircuit 230, are also controlled by the control circuit 220. Theseswitches are selectively closed and opened to form the EA stimulationpulses applied to the load, R_(LOAD). Before a stimulus pulse occurs,switch S_(R) is closed sufficiently long for the circuit side ofcoupling capacitor C_(C) to be charged to the output voltage, V_(OUT).The tissue side of C_(C) is maintained at 0 volts by the cathodeelectrode E2, which is maintained at ground reference. Then, for most ofthe time between stimulation pulses, both switches S_(R) and S_(P) arekept open, with a voltage approximately equal to the output voltageV_(OUT) appearing across the coupling capacitor C_(C).

At the leading edge of a stimulus pulse, the switch SP is closed, whichimmediately causes a negative voltage −V_(OUT) to appear across theload, R_(LOAD), causing the voltage at the anode E1 to also drop toapproximately −V_(OUT), thereby creating the leading edge of thestimulus pulse. This voltage starts to decay back to 0 volts ascontrolled by an RC (resistor-capacitance) time constant that is longcompared with the desired pulse width. At the trailing edge of thepulse, before the voltage at the anode E1 has decayed very much, theswitch S_(P) is open and the switch S_(R) is closed. This action causesthe voltage at the anode E1 to immediately (relatively speaking) returnto 0 volts, thereby defining the trailing edge of the pulse. With theswitch S_(R) closed, the charge on the circuit side of the couplingcapacitor C_(C) is allowed to charge back to V_(OUT) within a timeperiod controlled by a time constant set by the values of capacitorC_(C) and resistor R3. When the circuit side of the coupling capacitorC_(C) has been charged back to V_(OUT), then switch S_(R) is opened, andboth switches S_(R) and S_(P) remain open until the next stimulus pulseis to be generated. Then the process repeats each time a stimulus pulseis to be applied across the load.

Thus, it is seen that in one embodiment of the electronic circuitry usedwithin the IEAD 100, as shown in FIG. 10, a boost converter circuit 200is employed which can be shut down with a control signal. The controlsignal is ideally a digital control signal generated by a controlcircuit 220 (which may be realized using a microprocessor or equivalentcircuit). The control signal is applied to the low side (ground side) ofthe boost converter circuit 200 (identified as the “shutdown” terminalin FIG. 10). A capacitor CF supplies instantaneous current for the shortON time that the control signal enables the boost converter circuit tooperate. And, the capacitor CF is recharged from the battery during therelatively long OFF time when the control signal disables the boostconverter circuit.

An alternate embodiment of the electronic circuitry that may be usedwithin the IDEA 100 is shown in FIG. 11. This circuit is in mostrespects the same as the circuitry shown in FIG. 10. However, in thisalternate embodiment shown in FIG. 11, the boost converter circuit 200does not have a specific shut down input control. Rather, as seen inFIG. 11, the boost converter circuit is shut down by applying a controlvoltage to the feedback input of the boost converter circuit 200 that ishigher than V_(REF). When this happens, i.e., when the control voltageapplied to the feedback input is greater than V_(REF), the boostconverter will stop switching and draws little or no current from thebattery. The value of V_(REF) is typically a low enough voltage, such asa 1.2 V band-gap voltage, that a low level digital control signal can beused to disable the boost converter circuit. To enable the boostconverter circuit, the control signal can be set to go to a highimpedance, which effectively returns the node at the V_(REF) terminal tothe voltage set by the resistor divider network formed from R1 and R2.Alternatively the control signal can be set to go to a voltage less thanV_(REF).

A low level digital control signal that performs this function ofenabling (turning ON) or disabling (turning OFF) the boost convertercircuit is depicted in FIG. 11 as being generated at the output of acontrol circuit 220. The signal line on which this control signal ispresent connects the output of the control circuit 220 with the V_(REF)node connected to the feedback input of the boost converter circuit.This control signal, as suggested by the waveform shown in FIG. 11,varies from a voltage greater than V_(REF), thereby disabling or turningOFF the boost converter circuit, to a voltage less than V_(REF), therebyenabling or turning the boost converter circuit ON.

A refinement to the alternate embodiment shown in FIG. 11 is to use thecontrol signal to drive the low side of R2 as shown in FIG. 12. That is,as shown in FIG. 12, the boost converter circuit 200 is shut down whenthe control signal is greater than V_(REF) and runs when the controlsignal is less than V_(REF). A digital control signal can be used toperform this function by switching between ground and a voltage greaterthan V_(REF). This has the additional possibility of delta-sigmamodulation control of V_(OUT) if a measurement of the actual V_(OUT) isavailable for feedback, e.g., using a signal line 222, to thecontroller.

One preferred embodiment of the circuitry used in an implantableelectroacupuncture device (IEAD) 100 that employs a digital controlsignal as taught herein is shown in the schematic diagram shown in FIG.13A. In FIG. 13A, there are basically four integrated circuits (ICs)used as the main components. The IC U1 is a boost converter circuit, andperforms the function of the boost converter circuit 200 describedpreviously in connection with FIGS. 8B, 10, 11 and 12.

The IC U2 is a micro-controller IC and is used to perform the functionof the control circuit 220 described previously in connection with FIGS.10, 11 and 12. A preferred IC for this purpose is a MSP430G24521micro-controller chip made by Texas Instruments. This chip includes 8 KBof Flash memory. Having some memory included with the micro-controlleris important because it allows the parameters associated with a selectedstimulation regimen to be defined and stored. One of the advantages ofthe IEAD described herein is that it provides a stimulation regimen thatcan be defined with just 5 parameters, as taught below in connectionwith FIGS. 15A and 15B. This allows the programming features of themicro-controller to be carried out in a simple and straightforwardmanner.

The micro-controller U2 primarily performs the function of generatingthe digital signal that shuts down the boost converter to prevent toomuch instantaneous current from being drawn from the battery V_(BAT).The micro-controller U2 also controls the generation of the stimuluspulses at the desired pulse width and frequency. It further keeps trackof the time periods associated with a stimulation session, i.e., when astimulation session begins and when it ends.

The micro-controller U2 also controls the amplitude of the stimuluspulse. This is done by adjusting the value of a current generated by aProgrammable Current Source U3. In one embodiment, U3 is realized with avoltage controlled current source IC. In such a voltage controlledcurrent source, the programmed current is set by a programmed voltageappearing across a fixed resistor R5, i.e., the voltage appearing at the“OUT” terminal of U3. This programmed voltage, in turn, is set by thevoltage applied to the “SET” terminal of U3. That is, the programmedcurrent source U3 sets the voltage at the “OUT” terminal to be equal tothe voltage applied to the “SET” terminal. The programmed current thatflows through the resistor R5 is then set by Ohms Law to be the voltageat the “set” terminal divided by R5. As the voltage at the “set”terminal changes, the current flowing through resistor R5 at the “OUT”terminal changes, and this current is essentially the same as thecurrent pulled through the closed switch M1, which is essentially thesame current flowing through the load R_(LOAD). Hence, whatever currentflows through resistor R5, as set by the voltage across resistor R5, isessentially the same current that flows through the load R_(LOAD). Thus,as the micro-controller U2 sets the voltage at the “set” terminal of U3,on the signal line labeled “AMPSET”, it controls what current flowsthrough the load R_(LOAD). In no event can the amplitude of the voltagepulse developed across the load R_(LOAD) exceed the voltage V_(OUT)developed by the boost converter less the voltage drops across theswitches and current source.

The switches S_(R) and S_(P) described previously in connection withFIGS. 10, 11 and 12 are realized with transistor switches M1, M2, M3,M4, M5 and M6, each of which is controlled directly or indirectly bycontrol signals generated by the micro-controller circuit U2. For theembodiment shown in FIG. 13A, these switches are controlled by twosignals, one appearing on signal line 234, labeled PULSE, and the otherappearing on signal line 236, labeled RCHG (which is an abbreviation for“recharge”). For the circuit configuration shown in FIG. 13A, the RCHGsignal on signal line 236 is always the inverse of the PULSE signalappearing on signal line 234. This type of control does not allow bothswitch M1 and switch M2 to be open or closed at the same time. Rather,switch M1 is closed when switch M2 is open, and switch M2 is closed,when switch M1 is open. When switch M1 is closed, and switch M2 is open,the stimulus pulse appears across the load, R_(LOAD), with the currentflowing through the load, R_(LOAD), being essentially equal to thecurrent flowing through resistor R5. When the switch M1 is open, andswitch M2 is closed, no stimulus pulse appears across the load, and thecoupling capacitors C5 and C6 are recharged through the closed switch M2and resistor R6 to the voltage V_(OUT) in anticipation of the nextstimulus pulse.

The circuitry shown in FIG. 13A is only exemplary of one type of circuitthat may be used to control the pulse width, amplitude, frequency, andduty cycle of stimulation pulses applied to the load, R_(LOAD). Any typeof circuit, or control, that allows stimulation pulses of a desiredmagnitude (measured in terms of pulse width, frequency and amplitude,where the amplitude may be measured in current or voltage) to be appliedthrough the electrodes to the patient at the specified acupoint at adesired duty cycle (stimulation session duration and frequency) may beused. However, for the circuitry to perform its intended function over along period of time, e.g., years, using only a small energy source,e.g., a small coin-sized battery having a high battery impedance and arelatively low capacity, the circuitry must be properly managed andcontrolled to prevent excessive current draw from the battery.

It is also important that the circuitry used in the IEAD 100, e.g., thecircuitry shown in FIGS. 10, 11, 12, 13A, or equivalents thereof, havesome means for controlling the stimulation current that flows throughthe load, R_(LOAD), which load may be characterized as the patient'stissue impedance at and around the acupoint being stimulated. Thistissue impedance, as shown in FIGS. 11 and 12, may typically vary frombetween about 300 ohms to 2000 ohms. Moreover, it not only varies fromone patient to another, but it varies over time. Hence, there is a needto control the current that flows through this variable load, R LOAD.One way of accomplishing this goal is to control the stimulationcurrent, as opposed to the stimulation voltage, so that the same currentwill flow through the tissue load regardless of changes that may occurin the tissue impedance over time. The use of a voltage controlledcurrent source U3, as shown in FIG. 13A, is one way to satisfy thisneed.

Still referring to FIG. 13A, a fourth IC U4 is connected to themicro-controller U2. For the embodiment shown in FIG. 13A, the IC U4 isan electromagnetic field sensor, and it allows the presence of anexternally-generated (non-implanted) electromagnetic field to be sensed.An “electromagnetic” field, for purposes of this application includesmagnetic fields, radio frequency (RF) fields, light fields, and thelike. The electromagnetic sensor may take many forms, such as anywireless sensing element, e.g., a pickup coil or RF detector, a photondetector, a magnetic field detector, and the like. When a magneticsensor is employed as the electromagnetic sensor U4, the magnetic fieldis generated using an External Control Device (ECD) 240 thatcommunicates wirelessly, e.g., through the presence or absence of amagnetic field, with the magnetic sensor U4. (A magnetic field, or othertype of field if a magnetic field is not used, is symbolicallyillustrated in FIG. 13A by the wavy line 242.) In its simplest form, theECD 240 may simply be a magnet, and modulation of the magnetic field isachieved simply by placing or removing the magnet next to or away fromthe IEAD. When other types of sensors (non-magnetic) are employed, theECD 240 generates the appropriate signal or field to be sensed by thesensor that is used.

Use of the ECD 240 provides a way for the patient, or medical personnel,to control the IEAD 100 after it has been implanted (or before it isimplanted) with some simple commands, e.g., turn the IEAD ON, turn theIEAD OFF, increase the amplitude of the stimulation pulses by oneincrement, decrease the amplitude of the stimulation pulses by oneincrement, and the like. A simple coding scheme may be used todifferentiate one command from another. For example, one coding schemeis time-based. That is, a first command is communicated by holding amagnet near the IEAD 100, and hence near the magnetic sensor U4contained within the IEAD 100, for differing lengths of time. If, forexample, a magnet is held over the IEAD for at least 2 seconds, but nomore than 7 seconds, a first command is communicated. If a magnet isheld over the IEAD for at least 11 seconds, but no more than 18 seconds,a second command is communicated, and so forth.

Another coding scheme that could be used is a sequence-based codingscheme. That is, application of 3 magnetic pulses may be used to signalone external command, if the sequence is repeated 3 times. A sequence of2 magnetic pulses, repeated twice, may be used to signal anotherexternal command. A sequence of one magnetic pulse, followed by asequence of two magnetic pulses, followed by a sequence of threemagnetic pulses, may be used to signal yet another external command.

Other simple coding schemes may also be used, such as the letters AA,RR, HO, BT, KS using international Morse code. That is, the Morse codesymbols for the letter “A” are dot dash, where a dot is a short magneticpulse, and a dash is a long magnetic pulse. Thus, to send the letter Ato the IEAD 100 using an external magnet, the user would hold the magnetover the area where the IEAD 100 is implanted for a short period oftime, e.g., one second or less, followed by holding the magnet over theIEAD for a long period of time, e.g., more than one second.

More sophisticated magnetic coding schemes may be used to communicate tothe micro-controller chip U2 the operating parameters of the IEAD 100.For example, using an electromagnet controlled by a computer, the pulsewidth, frequency, and amplitude of the EA stimulation pulses used duringeach stimulation session may be pre-set. Also, the frequency of thestimulation sessions can be pre-set. Additionally, a master reset signalcan be sent to the device in order to re-set these parameters to defaultvalues. These same operating parameters and commands may be re-sent atany time to the IEAD 100 during its useful lifetime should changes inthe parameters be desired or needed.

The current and voltage waveforms associated with the operation of theIEAD circuitry of FIG. 13A are shown in FIG. 13B. In FIG. 13B, thehorizontal axis is time, the left vertical axis is voltage, and theright vertical axis is current. The battery in this example has 160 Ohmsof internal impedance.

Referring to FIGS. 13A and 13B, during startup, the boost converter ONtime is approximately 30 microseconds applied every 7.8 milliseconds.This is sufficient to ramp the output voltage V_(OUT) up to over 10 Vwithin 2 seconds while drawing no more than about 1 mA from the batteryand inducing only 150 mV of input voltage ripple.

The electroacupuncture (EA) simulation pulses resulting from operationof the circuit of FIG. 13A have a width of 0.5 milliseconds and increasein amplitude from approximately 1 mA in the first pulse to approximately15 mA in the last pulse. The instantaneous current drawn from thebattery is less than 2 mA for the EA pulses and the drop in batteryvoltage is less than approximately 300 mV. The boost converter isenabled (turned ON) only during the instantaneous output current surgesassociated with the 0.5 milliseconds wide EA pulses.

Another preferred embodiment of the circuitry used in an implantableelectroacupuncture device (IEAD) 100 that employs a digital controlsignal as taught herein is shown in the schematic diagram of FIG. 14.The circuit shown in FIG. 14 is, in most respects, very similar to thecircuit described previously in connection with FIG. 13A. What is new inFIG. 14 is the inclusion of an external Schottky diode D4 at the outputterminal LX of the boost convertor U1 and the inclusion of a fifthintegrated circuit (IC) U5 that essentially performs the same functionas the switches M1-M6 shown in FIG. 13A.

The Schottky diode D5 helps isolate the output voltage V_(OUT) generatedby the boost converter circuit U1. This is important in applicationswhere the boost converter circuit U1 is selected and operated to providean output voltage V_(OUT) that is four or five times as great as thebattery voltage, V_(BAT). For example, in the embodiment for which thecircuit of FIG. 14 is designed, the output voltage V_(OUT) is designedto be nominally 15 volts using a battery that has a nominal batteryvoltage of only 3 volts. (In contrast, the embodiment shown in FIG. 13Ais designed to provide an output voltage that is nominally 10-12 volts,using a battery having a nominal output voltage of 3 volts.)

The inclusion of the fifth IC U5 in the circuit shown in FIG. 14 is, asindicated, used to perform the function of a switch. The other ICs shownin FIG. 14, U1 (boost converter), U2 (micro-controller), U3 (voltagecontrolled programmable current source) and U4 (electromagnetic sensor)are basically the same as the IC's U1, U2, U3 and U4 describedpreviously in connection with FIG. 13A.

The IC U5 shown in FIG. 14 functions as a single pole/double throw(SPDT) switch. Numerous commercially-available ICs may be used for thisfunction. For example, an ADG1419 IC, available from Analog DevicesIncorporated (ADI) may be used. In such IC U5, the terminal “D”functions as the common terminal of the switch, and the terminals “SA”and “SB” function as the selected output terminal of the switch. Theterminals “IN” and “EN” are control terminals to control the position ofthe switch. Thus, when there is a signal present on the PULSE line,which is connected to the “IN” terminal of U5, the SPDT switch U5connects the “D” terminal to the “SB” terminal, and the SPDT switch U5effectively connects the cathode electrode E1 to the programmablecurrent source U3. This connection thus causes the programmed current,set by the control voltage AMPSET applied to the SET terminal of theprogrammable current source U3, to flow through resistor R5, which inturn causes essentially the same current to flow through the load,R_(LOAD), present between the electrodes E1 and E2. When a signal is notpresent on the PULSE line, the SPDT switch U5 effectively connects thecathode electrode E1 to the resistor R6, which allows the couplingcapacitors C12 and C13 to recharge back to the voltage V_(OUT) providedby the boost converter circuit U2.

From the above description, it is seen that an implantable IEAD 100 isprovided that uses a digital control signal to duty-cycle limit theinstantaneous current drawn from the battery by a boost converter. Threedifferent exemplary configurations (FIGS. 10, 11 and 12) are taught forachieving this desired result, and two exemplary circuit designs thatmay be used to realize this result have been disclosed (FIGS. 13A and14). One configuration (FIG. 12) teaches the additional capability todelta-sigma modulate the boost converter output voltage.

Delta-sigma modulation is well described in the art. Basically, it is amethod for encoding analog signals into digital signals orhigher-resolution digital signals into lower-resolution digital signals.The conversion is done using error feedback, where the differencebetween the two signals is measured and used to improve the conversion.The low-resolution signal typically changes more quickly than thehigh-resolution signal and it can be filtered to recover the highresolution signal with little or no loss of fidelity. Delta-sigmamodulation has found increasing use in modern electronic components suchas converters, frequency synthesizers, switched-mode power supplies andmotor controllers. See, e.g., Wikipedia, Delta-sigma modulation.

II. F. Use and Operation

With the implantable electroacupuncture device (IDEA) 100 in hand, theIDEA 100 may be used most effectively to treat dyslipidemia or obesityby first pre-setting stimulation parameters that the device will useduring a stimulation session. FIG. 15A shows a timing waveform diagramillustrating the EA stimulation parameters used by the IEAD to generateEA stimulation pulses. As seen in FIG. 15A, there are basically fourparameters associated with a stimulation session. The time T1 definesthe duration (or pulse width) of a stimulus pulse. The time T2 definesthe time between the start of one stimulus pulse and the start of thenext stimulus pulse. The time T2 thus defines the period associated withthe frequency of the stimulus pulses. The frequency of the stimulationpulses is equal to 1/T2. The ratio of T1/T2 is typically quite low,e.g., less than 0.01. The duration of a stimulation session is definedby the time period T3. The amplitude of the stimulus pulses is definedby the amplitude A1. This amplitude may be expressed in either voltageor current.

Turning next to FIG. 15B, a timing waveform diagram is shown thatillustrates the manner in which the stimulation sessions areadministered in accordance with a preferred stimulation regimen. FIG.15B shows several stimulation sessions of duration T3, and how often thestimulation sessions occur. The stimulation regimen thus includes a timeperiod T4 which sets the time period from the start of one stimulationsession to the start of the next stimulation session. T4 thus is theperiod of the stimulation session frequency, and the stimulation sessionfrequency is equal to 1/T4.

In order to allow the applied stimulation to achieve its desired effecton the body tissue at the selected target stimulation site, the periodof the stimulation session T4 may be varied when the stimulationsessions are first applied. This can be achieved by employing a simplealgorithm within the circuitry of the EA device that changes the valueof T4 in an appropriate manner. For example, at start up, the period T4may be set to a minimum value, T4(min). Then, as time goes on, the valueof T4 is gradually increased until a desired value of T4, T4(final), isreached.

By way of example, if T4(min) is 1 day, and T4(final) is 7 days, thevalue of T4 may vary as follows once the stimulation sessions begin:T4=1 day for the duration between the first and second stimulationsessions, then 2 days for the duration between the second and thirdstimulation sessions, then 4 days for the duration between the third andfourth stimulation sessions, and then finally 7 days for the durationbetween all subsequent stimulation sessions after the fourth stimulationsession.

Rather than increasing the value of T4 from a minimum value to a maximumvalue using a simple doubling algorithm, as described in the previousparagraph, an enhancement is to use a table of session durations andintervals whereby the automatic session interval can be shorter for thefirst week or so. For example the 1st 30 minute session could bedelivered after 1 day. The 2^(nd) 30 minute session could be deliveredafter 2 days. The 3^(rd) 30 minute session could be delivered after 4days. Finally, the 4th 30 minute session could be delivered for allsubsequent sessions after 7 days.

If a triggered session is delivered completely, it advances the therapyschedule to the next table entry.

Another enhancement is that the initial set amplitude only takes effectif the subsequent triggered session is completely delivered. If thefirst session is aborted by a magnet application, the device reverts toa Shelf Mode. In this way, the first session is always a triggeredsession that occurs in the clinician setting.

Finally, the amplitude and place in the session table are saved innon-volatile memory when they change. This avoids a resetting of thetherapy schedule and need to reprogram the amplitude in the event of adevice reset.

One preferred set of parameters to use to define a stimulation regimenare

-   -   T1=0.5 milliseconds    -   T2=500 milliseconds    -   T3=60 minutes    -   T4=7 days (10,080 minutes)    -   A1=6 volts (across 1 kOhm), or 6 milliamperes (mA)

It is to be emphasized that the values shown above for the stimulationregimen are representative of only one preferred stimulation regimenthat could be used. Other stimulation regimens that could be used, andthe ranges of values that could be used for each of these parameters,are as defined in the claims.

It is also emphasized that the ranges of values presented in the claimsfor the parameters used with the invention have been selected after manymonths of careful research and study, and are not arbitrary. Forexample, the ratio of T3/T4, which sets the duty cycle, has beencarefully selected to be very low, e.g., no more than 0.05. Maintaininga low duty cycle of this magnitude represents a significant change overwhat others have attempted in the implantable stimulator art. Not onlydoes a very low duty cycle allow the battery itself to be small (coincell size), which in turn allows the IEAD housing to be very small,which makes the IEAD ideally suited for being used without leads,thereby making it relatively easy to implant the device at the desiredacupuncture site, but it also limits the frequency and duration ofstimulation sessions.

Limiting the frequency and duration of the stimulation sessions is a keyaspect of applicants' invention because it recognizes that sometreatments, such as treating dyslipidemia, are best done slowly andmethodically, over time, rather than quickly and harshly using largedoses of stimulation (or other treatments) aimed at forcing a rapidchange in the patient's condition. Moreover, applying treatments slowlyand methodically is more in keeping with traditional acupuncture methods(which, as indicated previously, are based on over 2500 years ofexperience). In addition, this slow and methodical conditioning isconsistent with the time scale for remodeling of the central nervoussystem needed to produce the sustained therapeutic effect. Thus,applicants have based their treatment regimens on theslow-and-methodical approach, as opposed to the immediate-and-forcedapproach adopted by many, if not most, prior art implantable electricalstimulators.

Once the stimulation regimen has been defined and the parametersassociated with it have been pre-set into the memory of themicro-controller circuit 220, the IEAD 100 needs to be implanted.Implantation is usually a simple procedure, and is described above inconnection with the description of FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1Gand/or 1H, as well as FIGS. 17A and/or 17B.

For treating the specific dyslipidemia or obesity targeted by thisembodiment of the invention, the specified acupoint(s) (or target tissuelocations) at which the EA stimulation pulses should be applied inaccordance with a selected stimulation regimen are selected from thegroup of acupoints that comprise ST36, SP4, ST37, ST40, SP6, SP9, KI6,LRB, or certain underlying nerves, the peroneal and saphenous nerves.

After implantation, the IEAD must be turned ON, and otherwisecontrolled, so that the desired stimulation regimen may be carried out.In one preferred embodiment, control of the IEAD after implantation, aswell as anytime after the housing of the IEAD has been hermeticallysealed, is performed as shown in the state diagram of FIG. 16. Eachcircle shown in FIG. 16 represents a “state” that the micro-controllerU2 (in FIG. 13A or 14) may operate in under the conditions specified. Asseen in FIG. 16, the controller U2 only operates in one of six states:(1) a “Set Amplitude” state, (2) a “Shelf Mode” state, (3) a “TriggeredSession” state, (4) a “Sleep” state, (5) an “OFF” state, and an (6)“Automatic Session” state. The “Automatic Session” state is the statethat automatically carries out the stimulation regimen using thepre-programmed parameters that define the stimulation regimen.

Shelf Mode is a low power state in which the IEAD is placed prior toshipment. After implant, commands are made through magnet application.Magnet application means an external magnet, typically a small hand-heldcylindrical magnet, is placed over the location where the IEAD has beenimplanted. With a magnet in that location, the magnetic sensor U4 sensesthe presence of the magnet and notifies the controller U2 of themagnet's presence.

From the “Shelf Mode” state, a magnet application for 10 seconds (M.10s) puts the IEAD in the “Set Amplitude” state. While in the “SetAmplitude” state, the stimulation starts running by generating pulses atzero amplitude, incrementing every five seconds until the patientindicates that a comfortable level has been reached. At that time, themagnet is removed to set the amplitude.

If the magnet is removed and the amplitude is non-zero (MΛA), the devicecontinues into the “Triggered Session” so the patient receives theinitial therapy. If the magnet is removed during “Set Amplitude” whilethe amplitude is zero (MΛĀ), the device returns to the Shelf Mode.

The Triggered Session ends and stimulation stops after the session time(T_(S)) has elapsed and the device enters the “Sleep” state. If a magnetis applied during a Triggered Session (M), the session aborts to the“OFF” state. If the magnet remains held on for 10 seconds (M.10 s) whilein the “OFF” state, the “Set Amplitude” state is entered with thestimulation level starting from zero amplitude as described.

If the magnet is removed (M) within 10 seconds while in the OFF state,the device enters the Sleep state. From the Sleep state, the deviceautomatically enters the Automatic Session state when the sessioninterval time has expired (T_(I)). The Automatic Session deliversstimulation for the session time (T_(S)) and the device returns to theSleep state. In this embodiment, the magnet has no effect once theAutomatic Session starts so that the full therapy session is delivered.

While in the Sleep state, if a magnet has not been applied in the last30 seconds (D) and a magnet is applied for a window between 20-25seconds and then removed (M.20:25 s), a Triggered Session is started. Ifthe magnet window is missed (i.e. magnet removed too soon or too late),the 30 second de-bounce period (D) is started. When de-bounce is active,no magnet must be detected for 30 seconds before a Triggered Session canbe initiated.

The session interval timer runs while the device is in Sleep state. Thesession interval timer is initialized when the device is woken up fromShelf Mode and is reset after each session is completely delivered. Thusabort of a triggered session by magnet application will not reset thetimer, the Triggered Session must be completely delivered.

The circuitry that sets the various states shown in FIG. 16 as afunction of externally-generated magnetic control commands, or otherexternally-generated command signals, is the micro-controller U2 (FIG.14), the processor U2 (FIG. 13A), or the control circuit 220 (FIGS. 10,11 and 12). Such processor-type circuits are programmable circuits thatoperate as directed by a program. The program is often referred to as“code”, or a sequence of steps that the processor circuit follows. The“code” can take many forms, and be written in many different languagesand formats, known to those of skill in the art. Representative “code”for the micro-controller U2 (FIG. 14) for controlling the states of theIEAD as shown in FIG. 16 is found in Appendix C, and incorporated byreference herein.

In the preceding description, various exemplary embodiments have beendescribed with reference to the accompanying drawings. It will, however,be evident that various modifications and changes may be made thereto,and additional embodiments may be implemented, without departing fromthe scope of the invention as set forth in the claims that follow. Forexample, certain features of one embodiment described herein may becombined with or substituted for features of another embodimentdescribed herein. The description and drawings are accordingly to beregarded in an illustrative rather than a restrictive sense and are notintended to be exhaustive or to limit the invention to any precise formdisclosed. Many modifications and variations are possible in light ofthe above teaching. Thus, while the invention(s) herein disclosed hasbeen described by means of specific embodiments and applicationsthereof, numerous modifications and variations could be made thereto bythose skilled in the art without departing from the scope of theinvention(s) set forth in the claims.

What is claimed is:
 1. A method, comprising: generating, by animplantable stimulator, stimulation sessions at a duty cycle that isless than 0.05, wherein the duty cycle is a ratio of T3 to T4, eachstimulation session included in the stimulation sessions has a durationof T3 minutes and occurs at a rate of once every T4 minutes, and theimplantable stimulator is powered by a primary battery located withinthe implantable stimulator and having an internal impedance greater than5 ohms; and applying, by the implantable stimulator in accordance withthe duty cycle, the stimulation sessions to a patient.
 2. The method ofclaim 1, wherein: a housing of the implantable stimulator is coin-sizedand coin-shaped; and the primary battery located within the implantablestimulator is a coin-cell battery.
 3. The method of claim 1, wherein theapplying of the stimulation sessions to the patient comprises applyingthe stimulation sessions to a location within the patient that comprisesat least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, and LR8.4. The method of claim 1, wherein T3 is at least 10 minutes and lessthan 60 minutes, and wherein T4 is at least 1440 minutes.
 5. The methodof claim 1, wherein the primary battery located within the implantablestimulator has a capacity of less than 60 milliamp-hours (mAh).
 6. Themethod of claim 1, wherein the applying of the stimulation sessions tothe patient is configured to treat at least one of obesity,dyslipidemia, and a genitourinary disease of the patient.
 7. The methodof claim 6, wherein the applying of the stimulation sessions isconfigured to treat the genitourinary disease, and wherein the applyingof the stimulation session comprises applying the stimulation sessionsto a tibial nerve of the patient.
 8. An implantable stimulator,comprising: a housing; pulse generation circuitry located within thehousing, the pulse generation circuitry configured to generatestimulation sessions at a duty cycle that is less than 0.05, and apply,in accordance with the duty cycle, the stimulation sessions to a patientby way of an electrode array communicatively coupled to the pulsegeneration circuitry; and a primary battery located within the housingand having an internal impedance greater than 5 ohms, the primarybattery configured to provide operating power to the pulse generationcircuitry; wherein the duty cycle is a ratio of T3 to T4, and eachstimulation session included in the stimulation sessions has a durationof T3 minutes and occurs at a rate of once every T4 minutes.
 9. Theimplantable stimulator of claim 8, wherein: the housing of theimplantable stimulator is coin-sized and coin-shaped; and the primarybattery located within the housing is a coin-cell battery.
 10. Theimplantable stimulator of claim 8, wherein the primary battery locatedwithin the housing has a capacity of less than 60 milliamp-hours (mAh).11. The implantable stimulator of claim 8, wherein: the electrode arraycomprises a central electrode of a first polarity centrally located on afirst surface of a housing of the implantable stimulator and an annularelectrode of a second polarity and that is spaced apart from the centralelectrode; and the pulse generation circuitry is configured to apply thestimulation sessions to the patient by way of the electrode array byapplying the stimulation sessions to the patient by way of the centralelectrode and the annular electrode.
 12. The implantable stimulator ofclaim 11, wherein the annular electrode is located on the first surfaceof the housing.
 13. The implantable stimulator of claim 11, wherein theannular electrode comprises a ring electrode located around a perimeteredge of the housing.
 14. The implantable stimulator of claim 8, wherein:the electrode array comprises a plurality of electrodes located on alead that is attached to the implantable stimulator; and the pulsegeneration circuitry is configured to apply the stimulation sessions tothe location by way of the electrode array by applying the stimulationsessions to the location by way of the plurality of electrodes locatedon the lead.
 15. The implantable stimulator of claim 8, wherein theapplying of the stimulation sessions to the patient is configured totreat at least one of obesity, dyslipidemia, and a genitourinary diseaseof the patient.
 16. An implantable stimulator, comprising: a housing;pulse generation circuitry located within the housing, the pulsegeneration circuitry configured to generate stimulation sessions at aduty cycle that is less than 0.05, and apply, in accordance with theduty cycle, the stimulation sessions to a patient by way of an electrodearray communicatively coupled to the pulse generation circuitry; and aprimary battery located within the housing and that is a coin-cellbattery, the primary battery configured to provide operating power tothe pulse generation circuitry; wherein the duty cycle is a ratio of T3to T4, and each stimulation session included in the stimulation sessionshas a duration of T3 minutes and occurs at a rate of once every T4minutes.
 17. The implantable stimulator of claim 16, wherein the primarybattery located within the housing has a capacity of less than 60milliamp-hours (mAh).
 18. The implantable stimulator of claim 16,wherein the internal impedance is greater than 5 ohms.
 19. Theimplantable stimulator of claim 16, wherein the applying of thestimulation sessions to the patient is configured to treat at least oneof obesity, dyslipidemia, and a genitourinary disease of the patient.20. The implantable stimulator of claim 16, wherein: the electrode arraycomprises a central electrode of a first polarity centrally located on afirst surface of a housing of the implantable stimulator and an annularelectrode of a second polarity and that is spaced apart from the centralelectrode; and the pulse generation circuitry is configured to apply thestimulation sessions to the patient by way of the electrode array byapplying the stimulation sessions to the patient by way of the centralelectrode and the annular electrode.